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Clinical Trial Results:
An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma

Summary
EudraCT number	2016-002218-36
Trial protocol	HU BE GB ES FR
Global end of trial date	09 Nov 2018

Results information
Results version number	v1(current)
This version publication date	27 Nov 2019
First version publication date	27 Nov 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I3Y-MC-JPCJ

ISRCTN number

US NCT number

NCT02981342

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16342

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

09 Nov 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

09 Nov 2018

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

12 Jan 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 19

Country: Number of subjects enrolled

United States: 33

Country: Number of subjects enrolled

Taiwan: 14

Country: Number of subjects enrolled

United Kingdom: 1

Country: Number of subjects enrolled

Israel: 11

Country: Number of subjects enrolled

Australia: 5

Country: Number of subjects enrolled

France: 8

Country: Number of subjects enrolled

Spain: 15

Worldwide total number of subjects

106

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Study was planned for stage 1 & stage 2. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

Screening details

Per protocol, no efficacy analysis was planned for safety lead in. Purpose of safety lead in was only safety evaluation. All efficacy was done on randomized pts.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)

Arm description

Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.

Arm type

Safety Lead in

Investigational medicinal product name

Abemaciclib

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles.

Investigational medicinal product name

Galunisertib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.

200mg Abemaciclib

Arm description

Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.

Arm type

Experimental

Investigational medicinal product name

Abemaciclib

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.

150mg Abemaciclib + 150mg LY3023414

Arm description

Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.

Arm type

Experimental

Investigational medicinal product name

Abemaciclib

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles.

Investigational medicinal product name

LY3023414

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received oral dose of 150mg LY3023414 twice daily for 28 day cycles.

Gemcitabine or Capecitabine

Arm description

Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.

Arm type

Standard care

Investigational medicinal product name

Gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle.

Investigational medicinal product name

Capecitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.

Number of subjects in period 1	150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Started	7	33	33	33
Received at least one dose of study drug	7	32	33	26
Completed	7	22	20	19
Not completed	0	11	13	14
Study Closed by Sponsor	-	-	1	1
Consent withdrawn by subject	-	-	3	1
Death	-	9	9	4
Randomized, Never Treated	-	1	-	7
Adverse event	-	-	-	1
Lost to follow-up	-	1	-	-

Baseline characteristics

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Reporting group title

150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)

Reporting group description

Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.

Reporting group title

200mg Abemaciclib

Reporting group description

Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.

Reporting group title

150mg Abemaciclib + 150mg LY3023414

Reporting group description

Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.

Reporting group title

Gemcitabine or Capecitabine

Reporting group description

Reporting group values	150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine	Total
Number of subjects	7	33	33	33	106
Age categorical
Units: Subjects
In utero					0
Preterm newborn infants (gestational age < 37 wks)					0
Newborns (0-27 days)					0
Infants and toddlers (28 days-23 months)					0
Children (2-11 years)					0
Adolescents (12-17 years)					0
Adults (18-64 years)					0
From 65-84 years					0
85 years and over					0
Age continuous
Units: years
arithmetic mean (standard deviation)	65.29 ± 6.99	61.09 ± 7.83	62.52 ± 8.97	66.85 ± 7.61	-
Gender categorical
Units: Subjects
Female	4	18	16	19	57
Male	3	15	17	14	49
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	2	4	3	9
Not Hispanic or Latino	7	30	28	24	89
Unknown or Not Reported	0	1	1	6	8
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0
Asian	0	7	5	4	16
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	1	3	4
White	7	26	26	25	84
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	1	1	2
Region of Enrollment
Units: Subjects
Belgium	0	8	6	5	19
United States	7	8	10	8	33
Taiwan	0	7	4	3	14
United Kingdom	0	1	0	0	1
Israel	0	2	4	5	11
Australia	0	1	1	3	5
France	0	1	1	6	8
Spain	0	5	7	3	15

End points

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Reporting group title

150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)

Reporting group description

Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.

Reporting group title

200mg Abemaciclib

Reporting group description

Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.

Reporting group title

150mg Abemaciclib + 150mg LY3023414

Reporting group description

Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.

Reporting group title

Gemcitabine or Capecitabine

Reporting group description

Subject analysis set title

150mg Abemaciclib + 150mg Galunisertib

Subject analysis set type

Per protocol

Subject analysis set description

Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.

Subject analysis set title

150mg Abemaciclib + 150mg LY3023414

Subject analysis set type

Per protocol

Subject analysis set description

Participants received oral dose of 150mg Abemaciclib along with 150mg LY302341 twice daily for 28 day cycles.

Primary: Stage 1: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

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End point title

Stage 1: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ^[1]

End point description

Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Analysis Population Description (APD): All randomized participants.

End point type

Primary

End point timeframe

Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	33	33	33
Units: percentage of Participants
number (confidence interval 95%)	15.2 (2.9 to 27.4)	12.1 (1.0 to 23.3)	36.4 (20 to 52.8)

Statistical Analysis 1

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0495

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical Analysis 2

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.023

Method

Cochran-Mantel-Haenszel

Confidence interval

Primary: Stage 2: Progression Free Survival (PFS)

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End point title

Stage 2: Progression Free Survival (PFS) ^[2]

End point description

PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date. APD: All randomized participants.

End point type

Primary

End point timeframe

Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months) Censored participants: Abemaciclib 200 mg: 3, Abemaciclib 150mg + LY3023414 150mg: 8, Gemcitabine & Capecitabine: 18;

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No participants were enrolled in stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled in stage 1. Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	33	33	33
Units: Months
median (confidence interval 95%)	1.68 (1.35 to 1.84)	1.81 (1.28 to 1.91)	3.25 (1.05 to 5.65)

Statistical Analysis 1

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0085

Method

Logrank

Confidence interval

Statistical Analysis 2

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0123

Method

Logrank

Confidence interval

Secondary: Stage 1: Objective Response Rate (ORR): Percentage of Participants with a Best Overall Response (BOR) of CR or PR

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End point title

Stage 1: Objective Response Rate (ORR): Percentage of Participants with a Best Overall Response (BOR) of CR or PR ^[3]

End point description

Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. APD: All randomized participants.

End point type

Secondary

End point timeframe

Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	33	33	33
Units: percentage of Participants
number (confidence interval 95%)	3 (0 to 8.9)	0 (0 to 0)	3 (0 to 8.9)

Statistical Analysis 1

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical Analysis 2

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3017

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))

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End point title

Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20)) ^[4]

End point description

Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax). All randomized participants who received at least one dose of Abemaciclib along with Galunisertib and had evaluable PK samples. Geometric CV is expressed as %.

End point type

Secondary

End point timeframe

Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)
Number of subjects analysed	4
Units: Nanogram per Millilitre (ng/mL)
geometric mean (geometric coefficient of variation)
Abemaciclib	356 ± 137
LSN2839567 (M2)	85.1 ± 66
LSN3106726 (M20)	153 ± 58

No statistical analyses for this end point

Secondary: Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414

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End point title

Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414 ^[5]

End point description

APD: Zero Participants Analyzed: AUC was not analyzed due to insufficient data collected. Geometric CV is expressed as %.

End point type

Secondary

End point timeframe

Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	150mg Abemaciclib + 150mg LY3023414
Number of subjects analysed	0 ^[6]
Units: nanogram*hour per Milliliter
geometric mean (geometric coefficient of variation)	±

Notes
[6] - Zero Participants Analyzed: AUC was not analyzed due to insufficient data collected.

No statistical analyses for this end point

Secondary: Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414

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End point title

Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414 ^[7]

End point description

Zero Participants Analyzed: Cmax was not analyzed due to insufficient data collected. Geometric CV is expressed as %.

End point type

Secondary

End point timeframe

Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned.

End point values	150mg Abemaciclib + 150mg LY3023414
Number of subjects analysed	0 ^[8]
Units: mm
geometric mean (geometric coefficient of variation)	±

Notes
[8] - Zero Participants Analyzed: Cmax was not analyzed due to insufficient data collected.

No statistical analyses for this end point

Secondary: Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD

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End point title

Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD ^[9]

End point description

APD: Data not reported, no patients were enrolled to stage 2.

End point type

Secondary

End point timeframe

Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	0 ^[10]	0 ^[11]	0 ^[12]
Units: Percentage of Participants
number (confidence interval 95%)	( to )	( to )	( to )

Notes
[10] - Data not reported, no patients were enrolled to stage 2.
[11] - Data not reported, no patients were enrolled to stage 2.
[12] - Data not reported, no patients were enrolled to stage 2.

No statistical analyses for this end point

Secondary: Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months

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End point title

Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months ^[13]

End point description

Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions & no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

End point type

Secondary

End point timeframe

Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months) APD: All randomized participants.

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	33	33	33
Units: percentage of participants
number (confidence interval 95%)	3 (0 to 8.9)	0 (0 to 0)	3 (0 to 8.9)

Statistical Analysis 1

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical Analysis 2

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3017

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Stage 2: Duration of Response (DoR)

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End point title

Stage 2: Duration of Response (DoR) ^[14]

End point description

DoR was not analyzed due to small sample size with PR data.

End point type

Secondary

End point timeframe

Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	0 ^[15]	0 ^[16]	0 ^[17]
Units: Months
median (confidence interval 95%)	( to )	( to )	( to )

Notes
[15] - DoR was not analyzed due to small sample size with PR data.
[16] - DoR was not analyzed due to small sample size with PR data.
[17] - DoR was not analyzed due to small sample size with PR data.

No statistical analyses for this end point

Secondary: Stage 2: Overall Survival (OS)

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End point title

Stage 2: Overall Survival (OS) ^[18]

End point description

OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1. APD: All randomized participants. Censored participants: Abemaciclib 200mg: 11, Abemaciclib 150mg + LY3023414 150mg: 12, Gemcitabine + Capecitabine: 21;

End point type

Secondary

End point timeframe

Baseline to Death from Any Cause (Up to 10 Months)

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	33	33	33 ^[19]
Units: Months
median (confidence interval 95%)	2.71 (1.97 to 5.36)	3.29 (1.97 to 5.03)	9999 (2.53 to 9999)

Notes
[19] - 9999 = N/A

Statistical Analysis 1

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1938

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

1.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.782

upper limit

3.272

Statistical Analysis 2

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2477

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

1.533

Confidence interval

level

95%

sides

2-sided

lower limit

0.746

upper limit

3.15

Secondary: Stage 2: Change from Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level

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End point title

Stage 2: Change from Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level ^[20]

End point description

No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1. APD: All randomized participants with baseline and post baseline CA 19-9 measurement.

End point type

Secondary

End point timeframe

Baseline, 6 Months

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	24	21	20
Units: U/mL
arithmetic mean (standard deviation)	4281.53 ± 8177.89	3225.29 ± 5730.25	-501.17 ± 7198.70

No statistical analyses for this end point

Secondary: Stage 2: Change from Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

Top of page

End point title

Stage 2: Change from Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) ^[21]

End point description

mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1. APD: All randomized participants with baseline & post baseline value for the mBPI-sf specified item.

End point type

Secondary

End point timeframe

Baseline, 6 Months

Notes
[21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	19	14	13
Units: score on a scale
least squares mean (standard error)
Pain at its Worst in Last 24 hours	0.63 ± 0.47	-0.33 ± 0.55	-0.02 ± 0.57
Pain at its Least in Last 24 hours	0.86 ± 0.42	0.18 ± 0.49	0.39 ± 0.51
Pain on the Average	0.62 ± 0.45	-0.03 ± 0.51	-0.07 ± 0.53
Pain Right Now	0.38 ± 0.34	0.34 ± 0.59	-0.38 ± 0.61
Pain Interfered General Activity	0.64 ± 0.47	0.07 ± 0.55	0.22 ± 0.57
Pain Interfered with Mood	0.54 ± 0.41	0.28 ± 0.48	0.60 ± 0.50
Pain Interfered Walking Ability	0.05 ± 0.55	0.83 ± 0.64	0.19 ± 0.67
Pain Interfered with Normal Work	1.07 ± 0.51	0.66 ± 0.59	0.19 ± 0.61
Pain Interfered with Relations	0.39 ± 0.52	0.67 ± 0.61	0.26 ± 0.63
Pain Interfered with Sleep	0.19 ± 0.53	0.34 ± 0.61	-0.56 ± 0.65
Pain Interfered Enjoyment of Life	0.69 ± 0.62	0.39 ± 0.72	-0.13 ± 0.75
BPI Mean Pain Interference Score	0.55 ± 0.44	0.50 ± 0.51	0.05 ± 0.54

Statistical Analysis 1

Statistical analysis description

Pain at its Worst in Last 24 Hours

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[22]

P-value

= 0.383

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.65

Confidence interval

level

95%

sides

2-sided

lower limit

-0.84

upper limit

2.13

Variability estimate

Standard error of the mean

Dispersion value

0.74

Notes
[22] - Pain at its Worst in Last 24 Hours

Statistical Analysis 2

Statistical analysis description

Pain at its Worst in Last 24 Hours

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[23]

P-value

= 0.692

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-1.91

upper limit

1.28

Variability estimate

Standard error of the mean

Dispersion value

0.79

Notes
[23] - Pain at its Worst in Last 24 Hours

Statistical Analysis 3

Statistical analysis description

Pain at its Least in Last 24 Hours

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.469

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.48

Confidence interval

level

95%

sides

2-sided

lower limit

-0.85

upper limit

1.8

Variability estimate

Standard error of the mean

Dispersion value

0.66

Statistical Analysis 4

Statistical analysis description

Pain at its Least in Last 24 Hours

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[24]

P-value

= 0.776

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.62

upper limit

1.22

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[24] - Pain at its Least in Last 24 Hours

Statistical Analysis 5

Statistical analysis description

Pain on the Average

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[25]

P-value

= 0.328

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.69

Confidence interval

level

95%

sides

2-sided

lower limit

-0.72

upper limit

2.11

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[25] - Pain on the Average

Statistical Analysis 6

Statistical analysis description

Pain on the Average

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[26]

P-value

= 0.954

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-1.45

upper limit

1.54

Variability estimate

Standard error of the mean

Dispersion value

0.74

Notes
[26] - Pain on the Average

Statistical Analysis 7

Statistical analysis description

Pain Right Now

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[27]

P-value

= 0.35

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

-0.85

upper limit

2.36

Variability estimate

Standard error of the mean

Dispersion value

0.8

Notes
[27] - Pain Right Now

Statistical Analysis 8

Statistical analysis description

Pain on the Average

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[28]

P-value

= 0.405

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.72

Confidence interval

level

95%

sides

2-sided

lower limit

-1.01

upper limit

2.44

Variability estimate

Standard error of the mean

Dispersion value

0.85

Notes
[28] - Pain on the Average

Statistical Analysis 9

Statistical analysis description

Pain Interfered General Activity

Comparison groups

Gemcitabine or Capecitabine v 200mg Abemaciclib

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[29]

P-value

= 0.565

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.43

Confidence interval

level

95%

sides

2-sided

lower limit

-1.06

upper limit

1.91

Variability estimate

Standard error of the mean

Dispersion value

0.73

Notes
[29] - Pain Interfered General Activity

Statistical Analysis 10

Statistical analysis description

Pain Interfered General Activity

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[30]

P-value

= 0.848

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-1.74

upper limit

1.43

Variability estimate

Standard error of the mean

Dispersion value

0.79

Notes
[30] - Pain Interfered General Activity

Statistical Analysis 11

Statistical analysis description

Pain Interfered with Mood

Comparison groups

Gemcitabine or Capecitabine v 200mg Abemaciclib

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[31]

P-value

= 0.928

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-1.37

upper limit

1.25

Variability estimate

Standard error of the mean

Dispersion value

0.65

Notes
[31] - Pain Interfered with Mood

Statistical Analysis 12

Statistical analysis description

Pain Interfered with Mood

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[32]

P-value

= 0.65

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-0.32

Confidence interval

level

95%

sides

2-sided

lower limit

-1.71

upper limit

1.08

Variability estimate

Standard error of the mean

Dispersion value

0.69

Notes
[32] - Pain Interfered with Mood

Statistical Analysis 13

Statistical analysis description

Pain Interfered Walking Ability

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[33]

P-value

= 0.865

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-1.89

upper limit

1.6

Variability estimate

Standard error of the mean

Dispersion value

0.86

Notes
[33] - Pain Interfered Walking Ability

Statistical Analysis 14

Statistical analysis description

Pain Interfered Walking Ability

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[34]

P-value

= 0.497

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

-1.23

upper limit

2.5

Variability estimate

Standard error of the mean

Dispersion value

0.92

Notes
[34] - Pain Interfered Walking Ability

Statistical Analysis 15

Statistical analysis description

Pain Interfered with Normal Work

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[35]

P-value

= 0.272

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.89

Confidence interval

level

95%

sides

2-sided

lower limit

-0.72

upper limit

2.5

Variability estimate

Standard error of the mean

Dispersion value

0.8

Notes
[35] - Pain Interfered with Normal Work

Statistical Analysis 16

Statistical analysis description

Pain Interfered with Normal Work

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[36]

P-value

= 0.583

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-1.25

upper limit

2.19

Variability estimate

Standard error of the mean

Dispersion value

0.85

Notes
[36] - Pain Interfered with Normal Work

Statistical Analysis 17

Statistical analysis description

Pain Interfered with Relations

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[37]

P-value

= 0.876

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-1.53

upper limit

1.79

Variability estimate

Standard error of the mean

Dispersion value

0.82

Notes
[37] - Pain Interfered with Relations

Statistical Analysis 18

Statistical analysis description

Pain Interfered with relations.

Comparison groups

Gemcitabine or Capecitabine v 150mg Abemaciclib + 150mg LY3023414

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.644

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.41

Confidence interval

level

95%

sides

2-sided

lower limit

-1.37

upper limit

2.19

Variability estimate

Standard error of the mean

Dispersion value

0.88

Statistical Analysis 19

Statistical analysis description

Pain Interfered with Sleep

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[38]

P-value

= 0.384

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

-0.97

upper limit

2.48

Variability estimate

Standard error of the mean

Dispersion value

0.85

Notes
[38] - Pain Interfered with Sleep

Statistical Analysis 20

Statistical analysis description

Pain Interfered with sleep.

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.318

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

2.71

Variability estimate

Standard error of the mean

Dispersion value

0.89

Statistical Analysis 21

Statistical analysis description

Pain Interfered Enjoyment of Life

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[39]

P-value

= 0.407

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.81

Confidence interval

level

95%

sides

2-sided

lower limit

-1.15

upper limit

2.78

Variability estimate

Standard error of the mean

Dispersion value

0.97

Notes
[39] - Pain Interfered Enjoyment of Life

Statistical Analysis 22

Statistical analysis description

Pain Interfered Enjoyment of Life

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[40]

P-value

= 0.62

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

-1.58

upper limit

2.62

Variability estimate

Standard error of the mean

Dispersion value

1.04

Notes
[40] - Pain Interfered Enjoyment of Life

Statistical Analysis 23

Statistical analysis description

BPI-Mean Interference Score

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[41]

P-value

= 0.475

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

1.91

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[41] - BPI-Mean Interference Score

Statistical Analysis 24

Statistical analysis description

BPI-Mean Interference Score

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[42]

P-value

= 0.54

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.46

Confidence interval

level

95%

sides

2-sided

lower limit

-1.04

upper limit

1.96

Variability estimate

Standard error of the mean

Dispersion value

0.74

Notes
[42] - BPI-Mean Interference Score

Secondary: Stage 2: Change from Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

Top of page

End point title

Stage 2: Change from Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) ^[43]

End point description

The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions: 1) Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent). 2) Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much) 3) Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much). Raw scores are linearly converted to a 0–100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.

End point type

Secondary

End point timeframe

Baseline, 6 Months APD: All randomized participants with baseline & post baseline value for the EORTC QLQ-C30 specified item.

Notes
[43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	200mg Abemaciclib	150mg Abemaciclib + 150mg LY3023414	Gemcitabine or Capecitabine
Number of subjects analysed	19	14	14
Units: units on a scale
least squares mean (standard error)
Global Health Status	-6.21 ± 3.87	-4.82 ± 4.50	-2.40 ± 4.64
Functional Scales: Physical Functioning	-14.44 ± 4.40	-11.65 ± 5.12	-5.42 ± 5.12
Functional Scales: Role Functioning	-17.09 ± 6.17	-18.05 ± 7.32	-17.10 ± 7.36
Functional Scales: Emotional Functioning	-4.89 ± 4.49	-0.63 ± 5.22	2.06 ± 5.41
Functional Scales: Cognitive Functioning	-10.43 ± 4.10	-8.39 ± 4.77	-5.18 ± 4.95
Functional Scale: Social Functioning	-21.12 ± 4.90	-17.09 ± 5.72	-2.00 ± 5.95
Symptom Scales: Fatigue	14.13 ± 4.92	14.90 ± 5.73	5.64 ± 5.71
Symptom Scales: Nausea and Vomiting	7.98 ± 5.57	9.42 ± 6.47	11.88 ± 6.50
Symptom Scales: Pain	9.79 ± 5.63	2.68 ± 6.61	5.43 ± 6.62
Symptom Scale: Dysopnea	0.35 ± 5.48	11.19 ± 6.38	-4.51 ± 6.36
Symptom Scale: Insomnia	-5.19 ± 5.17	1.83 ± 6.01	-6.71 ± 6.05
Symptom Scale: Appetite Loss	12.54 ± 5.79	15.32 ± 6.77	9.51 ± 7.30
Symptom Scale: Constipation	2.96 ± 5.95	-6.51 ± 6.96	12.93 ± 7.15
Symptom Scale: Diarrhoea	15.71 ± 6.76	26.28 ± 7.83	20.51 ± 7.98
Symptom Scale: Financial difficulties	3.96 ± 4.82	2.45 ± 5.68	-3.30 ± 5.87

Statistical Analysis 1

Statistical analysis description

Global health status

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.818

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-1.39

Confidence interval

level

95%

sides

2-sided

lower limit

-13.46

upper limit

10.68

Variability estimate

Standard error of the mean

Dispersion value

5.98

Statistical Analysis 2

Statistical analysis description

Global health status

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.533

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-3.8

Confidence interval

level

95%

sides

2-sided

lower limit

-16.03

upper limit

8.42

Variability estimate

Standard error of the mean

Dispersion value

6.06

Statistical Analysis 3

Statistical analysis description

Functional Scales: Physical functioning

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.681

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-2.79

Confidence interval

level

95%

sides

2-sided

lower limit

-16.4

upper limit

10.82

Variability estimate

Standard error of the mean

Dispersion value

6.75

Statistical Analysis 4

Statistical analysis description

Functional Scales: Physical functioning

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.189

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-9.02

Confidence interval

level

95%

sides

2-sided

lower limit

-22.63

upper limit

4.59

Variability estimate

Standard error of the mean

Dispersion value

6.75

Statistical Analysis 5

Statistical analysis description

Functional Scales: Role functioning

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.921

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

-18.29

upper limit

20.21

Variability estimate

Standard error of the mean

Dispersion value

9.54

Statistical Analysis 6

Statistical analysis description

Functional Scales: Role functioning

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.999

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-19.4

upper limit

19.42

Variability estimate

Standard error of the mean

Dispersion value

9.62

Statistical Analysis 7

Statistical analysis description

Functional Scales: Emotional functioning

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.541

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-4.26

Confidence interval

level

95%

sides

2-sided

lower limit

-18.2

upper limit

9.68

Variability estimate

Standard error of the mean

Dispersion value

6.91

Statistical Analysis 8

Statistical analysis description

Functional Scales: Emotional functioning

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.33

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-6.95

Confidence interval

level

95%

sides

2-sided

lower limit

-21.17

upper limit

7.27

Variability estimate

Standard error of the mean

Dispersion value

7.05

Statistical Analysis 9

Statistical analysis description

Functional Scales: Cognitive Functioning

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.747

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-2.04

Confidence interval

level

95%

sides

2-sided

lower limit

-14.74

upper limit

10.66

Variability estimate

Standard error of the mean

Dispersion value

6.29

Statistical Analysis 10

Statistical analysis description

Functional Scales: Cognitive Functioning

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.419

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-5.25

Confidence interval

level

95%

sides

2-sided

lower limit

-18.22

upper limit

7.73

Variability estimate

Standard error of the mean

Dispersion value

6.43

Statistical Analysis 11

Statistical analysis description

Functional Scales: Social functioning

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.596

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-4.02

Confidence interval

level

95%

sides

2-sided

lower limit

-19.23

upper limit

11.19

Variability estimate

Standard error of the mean

Dispersion value

7.53

Statistical Analysis 12

Statistical analysis description

Functional Scales: Social functioning

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.017

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-19.12

Confidence interval

level

95%

sides

2-sided

lower limit

-34.68

upper limit

-3.55

Variability estimate

Standard error of the mean

Dispersion value

7.71

Statistical Analysis 13

Statistical analysis description

Symptoms Scales: Fatigue

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.919

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-16.03

upper limit

14.49

Variability estimate

Standard error of the mean

Dispersion value

7.57

Statistical Analysis 14

Statistical analysis description

Symptom Scales: Fatigue

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.267

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

8.48

Confidence interval

level

95%

sides

2-sided

lower limit

-6.72

upper limit

23.69

Variability estimate

Standard error of the mean

Dispersion value

7.54

Statistical Analysis 15

Statistical analysis description

Symptom Scales: Nausea and Vomiting

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.866

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-1.45

Confidence interval

level

95%

sides

2-sided

lower limit

-18.66

upper limit

15.77

Variability estimate

Standard error of the mean

Dispersion value

8.54

Statistical Analysis 16

Statistical analysis description

Symptom Scales: Nausea and Vomiting

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.652

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-3.9

Confidence interval

level

95%

sides

2-sided

lower limit

-21.23

upper limit

13.43

Variability estimate

Standard error of the mean

Dispersion value

8.59

Statistical Analysis 17

Statistical analysis description

Symptom Scales: Pain

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.417

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

7.11

Confidence interval

level

95%

sides

2-sided

lower limit

-10.39

upper limit

24.6

Variability estimate

Standard error of the mean

Dispersion value

8.67

Statistical Analysis 18

Statistical analysis description

Symptom Scales: Pain

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.618

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

4.36

Confidence interval

level

95%

sides

2-sided

lower limit

-13.16

upper limit

21.89

Variability estimate

Standard error of the mean

Dispersion value

8.69

Statistical Analysis 19

Statistical analysis description

Symptom Scales: Dyspnoea

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.206

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-10.84

Confidence interval

level

95%

sides

2-sided

lower limit

-27.85

upper limit

6.18

Variability estimate

Standard error of the mean

Dispersion value

8.44

Statistical Analysis 20

Statistical analysis description

Symptom Scales: Dyspnoea

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.566

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

4.86

Confidence interval

level

95%

sides

2-sided

lower limit

-12.08

upper limit

21.8

Variability estimate

Standard error of the mean

Dispersion value

8.4

Statistical Analysis 21

Statistical analysis description

Symptom Scales: Insomnia

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.38

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-7.02

Confidence interval

level

95%

sides

2-sided

lower limit

-23.01

upper limit

8.96

Variability estimate

Standard error of the mean

Dispersion value

7.93

Statistical Analysis 22

Statistical analysis description

Symptom Scales: Insomnia

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.85

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

1.52

Confidence interval

level

95%

sides

2-sided

lower limit

-14.6

upper limit

17.64

Variability estimate

Standard error of the mean

Dispersion value

7.99

Statistical Analysis 23

Statistical analysis description

Symptom Scales: Appetite loss

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.756

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-2.79

Confidence interval

level

95%

sides

2-sided

lower limit

-20.78

upper limit

15.21

Variability estimate

Standard error of the mean

Dispersion value

8.91

Statistical Analysis 24

Statistical analysis description

Symptom Scales: Appetite loss

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.747

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

3.02

Confidence interval

level

95%

sides

2-sided

lower limit

-15.77

upper limit

21.82

Variability estimate

Standard error of the mean

Dispersion value

9.31

Statistical Analysis 25

Statistical analysis description

Symptom Scales: Constipation

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.311

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

9.47

Confidence interval

level

95%

sides

2-sided

lower limit

-9.16

upper limit

28.09

Variability estimate

Standard error of the mean

Dispersion value

9.23

Statistical Analysis 26

Statistical analysis description

Symptom Scales: Constipation

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.29

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-9.97

Confidence interval

level

95%

sides

2-sided

lower limit

-28.75

upper limit

8.8

Variability estimate

Standard error of the mean

Dispersion value

9.3

Statistical Analysis 27

Statistical analysis description

Symptom Scales: Diarrhoea

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.323

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-10.57

Confidence interval

level

95%

sides

2-sided

lower limit

-31.93

upper limit

10.78

Variability estimate

Standard error of the mean

Dispersion value

10.58

Statistical Analysis 28

Statistical analysis description

Symptom Scales: Diarrhoea

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.651

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

-4.8

Confidence interval

level

95%

sides

2-sided

lower limit

-26.08

upper limit

16.48

Variability estimate

Standard error of the mean

Dispersion value

10.54

Statistical Analysis 29

Statistical analysis description

Symptom Scales: Financial Difficulties

Comparison groups

200mg Abemaciclib v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.841

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

1.51

Confidence interval

level

95%

sides

2-sided

lower limit

-13.57

upper limit

16.59

Variability estimate

Standard error of the mean

Dispersion value

7.47

Statistical Analysis 30

Statistical analysis description

Symptom Scales: Financial Difficulties

Comparison groups

150mg Abemaciclib + 150mg LY3023414 v Gemcitabine or Capecitabine

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.344

Method

Mixed models analysis

Parameter type

LSMean Difference

Point estimate

7.26

Confidence interval

level

95%

sides

2-sided

lower limit

-8.03

upper limit

22.54

Variability estimate

Standard error of the mean

Dispersion value

7.57

Secondary: Stage 1: PK: Steady state trough pre dose concentration of LY3023414

Top of page

End point title

Stage 1: PK: Steady state trough pre dose concentration of LY3023414 ^[44]

End point description

Mean steady state exposure was reported by trough pre-dose plasma concentrations. Geometric CV is expressed as %.

End point type

Secondary

End point timeframe

C2D1: 0h, C3D1: 0h, C4D1: 0h

Notes
[44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned for all arms.

End point values	150mg Abemaciclib + 150mg LY3023414
Number of subjects analysed	9
Units: ng/mL
geometric mean (geometric coefficient of variation)	27.3 ± 450

No statistical analyses for this end point

Secondary: Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose

Top of page

End point title

Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose ^[45]

End point description

Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose. Geometric CV is expressed as %.

End point type

Secondary

End point timeframe

C1D1: 2h Post dose

Notes
[45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Per protocol, statistical analysis was not planned.

End point values	150mg Abemaciclib + 150mg LY3023414
Number of subjects analysed	28
Units: ng/mL
geometric mean (geometric coefficient of variation)	518 ± 67

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Up to 30 weeks

Adverse event reporting additional description

All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

Abema200mg

Reporting group description

Reporting group title

Abema150mg+LY3023414

Reporting group description

Reporting group title

Abema150mg+Gal_LI

Reporting group description

Reporting group title

Gem or Cap

Reporting group description

Serious adverse events	Abema200mg	Abema150mg+LY3023414	Abema150mg+Gal_LI	Gem or Cap
Total subjects affected by serious adverse events
subjects affected / exposed	17 / 32 (53.13%)	18 / 33 (54.55%)	4 / 7 (57.14%)	15 / 26 (57.69%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumour pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
deep vein thrombosis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
embolism
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypotension
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
chills
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
fatigue
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
general physical health deterioration
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
malaise
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
multiple organ dysfunction syndrome
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
pyrexia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
systemic inflammatory response syndrome
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
hypoxia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pleural effusion
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary embolism
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	1 / 33 (3.03%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
respiratory failure
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Psychiatric disorders
confusional state
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
mental status changes
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
blood creatinine increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
platelet count decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
white blood cell count decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
cerebrovascular accident
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
ischaemic cerebral infarction
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
febrile neutropenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
neutropenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
thrombocytopenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	8 / 8	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ascites
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diarrhoea
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
duodenal stenosis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastric ulcer haemorrhage
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrointestinal perforation
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
intestinal obstruction
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
large intestinal obstruction
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
nausea
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
obstruction gastric
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
oesophagitis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
stomatitis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
subileus
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vomiting
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	2 / 33 (6.06%)	0 / 7 (0.00%)	4 / 26 (15.38%)
occurrences causally related to treatment / all	0 / 2	2 / 2	0 / 0	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
bile duct obstruction
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cholangitis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 1	2 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cholangitis acute
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
back pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
muscular weakness
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
abdominal infection
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bacteraemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
escherichia bacteraemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
peritonitis bacterial
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sepsis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
upper respiratory tract infection
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
urosepsis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
acidosis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
decreased appetite
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dehydration
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
failure to thrive
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypokalaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hyponatraemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hypophosphataemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tumour lysis syndrome
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Abema200mg	Abema150mg+LY3023414	Abema150mg+Gal_LI	Gem or Cap
Total subjects affected by non serious adverse events
subjects affected / exposed	30 / 32 (93.75%)	33 / 33 (100.00%)	7 / 7 (100.00%)	25 / 26 (96.15%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumour pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	3	0	0	0
Vascular disorders
hot flush
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	1	1	0
hypotension
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 32 (9.38%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	3	1	1	0
peripheral coldness
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 32 (12.50%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	5	0	1	0
chills
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	2 / 33 (6.06%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	2	0	0
fatigue
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	16 / 32 (50.00%)	17 / 33 (51.52%)	4 / 7 (57.14%)	11 / 26 (42.31%)
occurrences all number	22	25	7	12
feeling cold
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
general physical health deterioration
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	2 / 33 (6.06%)	0 / 7 (0.00%)	3 / 26 (11.54%)
occurrences all number	1	3	0	3
malaise
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	1	0	1	0
non-cardiac chest pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	2 / 26 (7.69%)
occurrences all number	0	0	0	2
oedema
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
oedema peripheral
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 32 (12.50%)	5 / 33 (15.15%)	2 / 7 (28.57%)	1 / 26 (3.85%)
occurrences all number	4	6	2	1
peripheral swelling
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
pyrexia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 32 (9.38%)	5 / 33 (15.15%)	2 / 7 (28.57%)	0 / 26 (0.00%)
occurrences all number	5	6	2	0
Reproductive system and breast disorders
prostatomegaly
alternative dictionary used: MedDRA 20.0
subjects affected / exposed ^[1]	0 / 14 (0.00%)	1 / 17 (5.88%)	0 / 3 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0
Respiratory, thoracic and mediastinal disorders
atelectasis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
cough
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	2 / 33 (6.06%)	1 / 7 (14.29%)	2 / 26 (7.69%)
occurrences all number	2	2	1	2
dysphonia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	0	0	2	1
dyspnoea
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	4 / 33 (12.12%)	2 / 7 (28.57%)	3 / 26 (11.54%)
occurrences all number	2	5	2	5
hypoxia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	0	2	0	0
pleural effusion
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	0	2	1	1
pneumothorax
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	2 / 26 (7.69%)
occurrences all number	0	0	0	4
upper-airway cough syndrome
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	1	0	1	1
confusional state
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 32 (9.38%)	0 / 33 (0.00%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences all number	3	0	0	1
depression
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	1	1	1	0
insomnia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	0	3	0	0
Investigations
alanine aminotransferase increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 32 (12.50%)	0 / 33 (0.00%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	8	0	1	1
aspartate aminotransferase increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 32 (9.38%)	0 / 33 (0.00%)	2 / 7 (28.57%)	1 / 26 (3.85%)
occurrences all number	6	0	3	3
blood alkaline phosphatase increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	5 / 32 (15.63%)	3 / 33 (9.09%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	9	5	1	1
blood creatinine increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	3 / 33 (9.09%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	2	5	1	3
blood bilirubin increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	5 / 32 (15.63%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences all number	16	1	0	2
blood potassium decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	2	0	0	0
blood sodium decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	3	0	0	0
international normalised ratio increased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	2	0	0	0
lymphocyte count decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	0 / 33 (0.00%)	0 / 7 (0.00%)	2 / 26 (7.69%)
occurrences all number	3	0	0	4
neutrophil count decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 32 (12.50%)	1 / 33 (3.03%)	0 / 7 (0.00%)	2 / 26 (7.69%)
occurrences all number	7	3	0	8
occult blood positive
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
platelet count decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	10 / 32 (31.25%)	5 / 33 (15.15%)	0 / 7 (0.00%)	4 / 26 (15.38%)
occurrences all number	20	11	0	9
weight decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	3 / 33 (9.09%)	2 / 7 (28.57%)	1 / 26 (3.85%)
occurrences all number	0	3	2	1
white blood cell count decreased
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 32 (12.50%)	1 / 33 (3.03%)	2 / 7 (28.57%)	3 / 26 (11.54%)
occurrences all number	4	3	3	5
Injury, poisoning and procedural complications
fall
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	2 / 33 (6.06%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	2	0	0
Cardiac disorders
tachycardia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	1	1	1	0
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	3 / 33 (9.09%)	2 / 7 (28.57%)	0 / 26 (0.00%)
occurrences all number	1	3	2	0
dysgeusia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 32 (9.38%)	4 / 33 (12.12%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	3	4	0	0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	10 / 32 (31.25%)	6 / 33 (18.18%)	3 / 7 (42.86%)	11 / 26 (42.31%)
occurrences all number	18	7	14	19
cytopenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
leukopenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
neutropenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 32 (12.50%)	0 / 33 (0.00%)	2 / 7 (28.57%)	2 / 26 (7.69%)
occurrences all number	9	0	2	5
thrombocytopenia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	5 / 33 (15.15%)	0 / 7 (0.00%)	4 / 26 (15.38%)
occurrences all number	0	5	0	17
Eye disorders
photopsia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
visual impairment
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
Gastrointestinal disorders
abdominal distension
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	1	0	2	1
abdominal discomfort
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	2 / 7 (28.57%)	0 / 26 (0.00%)
occurrences all number	0	0	2	0
abdominal pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	7 / 32 (21.88%)	5 / 33 (15.15%)	1 / 7 (14.29%)	6 / 26 (23.08%)
occurrences all number	8	5	1	8
abdominal pain upper
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	1 / 7 (14.29%)	4 / 26 (15.38%)
occurrences all number	0	1	1	4
ascites
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 32 (12.50%)	2 / 33 (6.06%)	0 / 7 (0.00%)	3 / 26 (11.54%)
occurrences all number	5	2	0	3
constipation
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	5 / 32 (15.63%)	2 / 33 (6.06%)	1 / 7 (14.29%)	7 / 26 (26.92%)
occurrences all number	6	2	2	7
diarrhoea
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	12 / 32 (37.50%)	17 / 33 (51.52%)	4 / 7 (57.14%)	8 / 26 (30.77%)
occurrences all number	21	19	4	16
dry mouth
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	0	2	0	0
dyspepsia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	2	0	0	0
eructation
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
flatulence
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	2	1	0	0
gastrointestinal pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	1	0	1	0
nausea
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	9 / 32 (28.13%)	15 / 33 (45.45%)	5 / 7 (71.43%)	9 / 26 (34.62%)
occurrences all number	14	18	5	10
stomatitis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	12 / 33 (36.36%)	0 / 7 (0.00%)	6 / 26 (23.08%)
occurrences all number	0	16	0	9
vomiting
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	10 / 32 (31.25%)	15 / 33 (45.45%)	2 / 7 (28.57%)	6 / 26 (23.08%)
occurrences all number	12	22	3	8
Hepatobiliary disorders
bile duct obstruction
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	4 / 32 (12.50%)	0 / 33 (0.00%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	4	0	0	0
Skin and subcutaneous tissue disorders
dry skin
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	1 / 33 (3.03%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	1	1	1	1
ecchymosis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
palmar-plantar erythrodysaesthesia syndrome
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	0 / 7 (0.00%)	10 / 26 (38.46%)
occurrences all number	0	2	0	24
pruritus
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	2 / 33 (6.06%)	2 / 7 (28.57%)	1 / 26 (3.85%)
occurrences all number	2	2	2	1
rash
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	2 / 7 (28.57%)	0 / 26 (0.00%)
occurrences all number	0	1	3	0
rash maculo-papular
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	3 / 33 (9.09%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences all number	3	3	0	1
skin discolouration
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
skin ulcer
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	2 / 26 (7.69%)
occurrences all number	0	0	0	2
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	0 / 7 (0.00%)	3 / 26 (11.54%)
occurrences all number	2	0	0	3
haematuria
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
hydronephrosis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	0	0	1	1
Endocrine disorders
hypothyroidism
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal and connective tissue disorders
arthropathy
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
back pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 32 (9.38%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	3	0	1	0
flank pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	1	2	0
musculoskeletal pain
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
muscular weakness
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	0	3	0	0
myalgia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	1 / 33 (3.03%)	0 / 7 (0.00%)	0 / 26 (0.00%)
occurrences all number	3	2	0	0
pain in extremity
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	1 / 33 (3.03%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	0	1	1	1
Infections and infestations
bacterial sepsis
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
upper respiratory tract infection
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	0 / 7 (0.00%)	2 / 26 (7.69%)
occurrences all number	0	0	0	2
urinary tract infection
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	1	0	1	1
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	9 / 32 (28.13%)	8 / 33 (24.24%)	3 / 7 (42.86%)	8 / 26 (30.77%)
occurrences all number	11	9	4	8
dehydration
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	2 / 33 (6.06%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	0	2	1	1
failure to thrive
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
fluid retention
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
hyperglycaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	3 / 33 (9.09%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	0	5	1	1
hyperkalaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	2 / 33 (6.06%)	0 / 7 (0.00%)	2 / 26 (7.69%)
occurrences all number	2	2	0	2
hypoalbuminaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	3 / 33 (9.09%)	2 / 7 (28.57%)	1 / 26 (3.85%)
occurrences all number	1	3	5	1
hypokalaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 32 (9.38%)	3 / 33 (9.09%)	0 / 7 (0.00%)	4 / 26 (15.38%)
occurrences all number	4	3	0	5
hypocalcaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	4	0	2	0
hypomagnesaemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	3 / 32 (9.38%)	1 / 33 (3.03%)	1 / 7 (14.29%)	1 / 26 (3.85%)
occurrences all number	3	1	1	1
hyponatraemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	1 / 32 (3.13%)	3 / 33 (9.09%)	4 / 7 (57.14%)	1 / 26 (3.85%)
occurrences all number	1	6	6	1
hypophagia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	0 / 32 (0.00%)	0 / 33 (0.00%)	1 / 7 (14.29%)	0 / 26 (0.00%)
occurrences all number	0	0	1	0
hypophosphataemia
alternative dictionary used: MedDRA 20.0
subjects affected / exposed	2 / 32 (6.25%)	1 / 33 (3.03%)	0 / 7 (0.00%)	1 / 26 (3.85%)
occurrences all number	3	2	0	1

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Study was planned for stage 1 & stage 2. Stage 2 did not occur, no participants were enrolled to stage 2;

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Clinical trials

Clinical Trial Results: An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Stage 1: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

Primary: Stage 1: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

Primary: Stage 2: Progression Free Survival (PFS)

Primary: Stage 2: Progression Free Survival (PFS)

Secondary: Stage 1: Objective Response Rate (ORR): Percentage of Participants with a Best Overall Response (BOR) of CR or PR

Secondary: Stage 1: Objective Response Rate (ORR): Percentage of Participants with a Best Overall Response (BOR) of CR or PR

Secondary: Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))

Secondary: Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))

Secondary: Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414

Secondary: Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414

Secondary: Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414

Secondary: Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414

Secondary: Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD

Secondary: Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD

Secondary: Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months

Secondary: Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months

Secondary: Stage 2: Duration of Response (DoR)

Secondary: Stage 2: Duration of Response (DoR)

Secondary: Stage 2: Overall Survival (OS)

Secondary: Stage 2: Overall Survival (OS)

Secondary: Stage 2: Change from Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level

Secondary: Stage 2: Change from Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level

Secondary: Stage 2: Change from Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

Secondary: Stage 2: Change from Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

Secondary: Stage 2: Change from Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

Secondary: Stage 2: Change from Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

Secondary: Stage 1: PK: Steady state trough pre dose concentration of LY3023414

Secondary: Stage 1: PK: Steady state trough pre dose concentration of LY3023414

Secondary: Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose

Secondary: Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma