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Clinical Trial Results:
A randomized, open-label, phase 2 study of the IDO inhibitor INCB024360 versus tamoxifen for subjects with biochemical-recurrent-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer following complete remission with first-line chemotherapy

Summary
EudraCT number	2012-001472-10
Trial protocol	GB
Global end of trial date	23 Oct 2014

Results information
Results version number	v1(current)
This version publication date	05 Jan 2017
First version publication date	05 Jan 2017
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

INCB24360-210

ISRCTN number

-

US NCT number

NCT01685255

WHO universal trial number (UTN)

-

Sponsor organisation name

Incyte Corporation

Sponsor organisation address

1801 Augustine Cut-Off, Wilmington, United States, 19803

Public contact

Incyte Corporation Call Centre, Incyte Corporation, +44 (0)330 100 3677, globalmedinfo@incyte.com

Scientific contact

Incyte Corporation Call Centre, Incyte Corporation, +44 (0)330 100 3677, globalmedinfo@incyte.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

23 Oct 2014

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

23 Oct 2014

Was the trial ended prematurely?

Yes

Main objective of the trial

To determine efficacy based on investigator-assessed progression-free survival (PFS) of INCB024360 versus tamoxifen among subjects with CA 125 elevation following complete remission with first-line chemotherapy for advanced disease.

Protection of trial subjects

This study was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Conference on Harmonisation Guidelines.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

07 Mar 2013

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 7

Country: Number of subjects enrolled

Australia: 2

Country: Number of subjects enrolled

Canada: 2

Country: Number of subjects enrolled

Russian Federation: 16

Country: Number of subjects enrolled

Ukraine: 3

Country: Number of subjects enrolled

United States: 12

Worldwide total number of subjects

42

EEA total number of subjects

7

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

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)

27

From 65 to 84 years

15

85 years and over

0

Subject disposition

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Recruitment details

This study was conducted at 52 study centers, including 5 in Australia, 4 in Canada, 12 in Great Britain, 9 in Russia, 5 in Ukraine, and 17 in the United States.

Screening details

Subjects were randomized (1:1) to 1 of 2 treatment groups, INCB024360 or tamoxifen, and stratified based on the number of months since prior first-line chemotherapy to the time of their first CA 125 elevation (3 to < 12 months or ≥ 12 months).

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

INCB024360 600 mg BID

Arm description

Subjects randomized to Arm A (INCB024360) will take INCB024360 tablets at a dose of 600 mg BID, beginning on Day 1.

Arm type

Experimental

Investigational medicinal product name

INCB024360

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablets were taken approximately 12 hours apart, and at least 2 hours after a meal. Subjects were to abstain from food for 1 hour after administration.

Tamoxifen 20 mg BID

Arm description

Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.

Arm type

Active comparator

Investigational medicinal product name

tamoxifen

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.

Number of subjects in period 1	INCB024360 600 mg BID	Tamoxifen 20 mg BID
Started	22	20
Completed	0	0
Not completed	22	20
Disease progression	10	11
Adverse event, non-fatal	6	-
Termination of the clinical study by the sponsor	6	9

Baseline characteristics

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Reporting group title

INCB024360 600 mg BID

Reporting group description

Subjects randomized to Arm A (INCB024360) will take INCB024360 tablets at a dose of 600 mg BID, beginning on Day 1.

Reporting group title

Tamoxifen 20 mg BID

Reporting group description

Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.

Reporting group values	INCB024360 600 mg BID	Tamoxifen 20 mg BID	Total
Number of subjects	22	20	42
Age categorical
Units: Subjects
Adults (18-64 years)	14	13	27
From 65-84 years	8	7	15
Age continuous
Units: years
arithmetic mean (standard deviation)	60.8 ± 12.44	60.4 ± 9.91	-
Gender categorical
Units: Subjects
Female	22	20	42
Male	0	0	0

End points

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Reporting group title

INCB024360 600 mg BID

Reporting group description

Subjects randomized to Arm A (INCB024360) will take INCB024360 tablets at a dose of 600 mg BID, beginning on Day 1.

Reporting group title

Tamoxifen 20 mg BID

Reporting group description

Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.

Primary: Progression free survival (PFS)

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End point title

Progression free survival (PFS)

End point description

Progression-free survival, using RECIST criteria, was defined as the length of time between randomization and death or investigator-assessed progressive disease, whichever occurred earlier as determined by the investigator.

End point type

Primary

End point timeframe

PFS is defined as the number of days from randomization to the earlier of death or disease progression for up to 36 months.

End point values	INCB024360 600 mg BID	Tamoxifen 20 mg BID
Number of subjects analysed	22 ^[1]	20 ^[2]
Units: months
median (confidence interval 95%)	3.75 (2.01 to 7.43)	5.56 (1.68 to 9.24)

Notes
[1] - Modified Intent-to-Treat Subjects
[2] - Modified Intent-to-Treat Subjects

Summary of Progression-Free Survival

Comparison groups

Tamoxifen 20 mg BID v INCB024360 600 mg BID

Number of subjects included in analysis

42

Analysis specification

Pre-specified

Analysis type

equivalence

P-value

= 0.544

Method

Stratified Log-rank Test

Parameter type

Hazard ratio (HR)

Point estimate

1.344

Confidence interval

level

95%

sides

2-sided

lower limit

0.576

upper limit

3.136

Secondary: Percentage of participants with at least a 50% reduction in Cancer Antigen (CA) 125 levels

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End point title

Percentage of participants with at least a 50% reduction in Cancer Antigen (CA) 125 levels

End point description

A CA 125 response was defined as at least a 50% reduction in CA 125 levels from a pretreatment sample and that was maintained for at least 28 days.

End point type

Secondary

End point timeframe

CA 125 response rate defined as at least 50% reduction on study as compared to pretreatment sample; pre-treatment sample must be at least 2x ULN and response must be sustained for at least 28 days.

End point values	INCB024360 600 mg BID	Tamoxifen 20 mg BID
Number of subjects analysed	22 ^[3]	19 ^[4]
Units: Percentage of participants
number (not applicable)
Responders confirmed	5	15.8
Response but unconfirmed	10	10.5
Non-Responders	85	73.7

Notes
[3] - mITT Subjects
[4] - mITT Subjects

Cancer Antigen (CA) 125 response rate

Comparison groups

INCB024360 600 mg BID v Tamoxifen 20 mg BID

Number of subjects included in analysis

41

Analysis specification

Pre-specified

Analysis type

equivalence

P-value

= 0.3416

Method

Fisher exact

Confidence interval

Secondary: Overall survival

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End point title

Overall survival

End point description

Overall survival is reported here as the number of deaths from randomization until the data cut-off.

End point type

Secondary

End point timeframe

Overall survival followed every 12 weeks until last date known to be alive, until subjects withdraw consent or up to 36 months, whichever is longest.

End point values	INCB024360 600 mg BID	Tamoxifen 20 mg BID
Number of subjects analysed	22 ^[5]	20 ^[6]
Units: Participants
number (not applicable)
Death events	1	0
Censored events	21	20

Notes
[5] - Modified Intent-to-Treat
[6] - Modified Intent-to-Treat

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AEs were collected during study drug treatment period and within 60 days of the last dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

15.0

Reporting group title

INCB024360 600 mg BID

Reporting group description

Subjects randomized to Arm A (INCB024360) will take INCB024360 tablets at a dose of 600 mg BID, beginning on Day 1.

Reporting group title

Tamoxifen 20 mg BID

Reporting group description

Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.

Serious adverse events	INCB024360 600 mg BID	Tamoxifen 20 mg BID
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 22 (4.55%)	1 / 20 (5.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 22 (4.55%)	0 / 20 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	INCB024360 600 mg BID	Tamoxifen 20 mg BID
Total subjects affected by non serious adverse events
subjects affected / exposed	17 / 22 (77.27%)	15 / 20 (75.00%)
Cardiac disorders
Dyspnea
subjects affected / exposed	2 / 22 (9.09%)	3 / 20 (15.00%)
occurrences all number	3	3
Nervous system disorders
Headache
subjects affected / exposed	3 / 22 (13.64%)	3 / 20 (15.00%)
occurrences all number	3	3
General disorders and administration site conditions
Fatigue
subjects affected / exposed	8 / 22 (36.36%)	8 / 20 (40.00%)
occurrences all number	9	8
Asthenia
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)
occurrences all number	3	0
Influenza-like illness
subjects affected / exposed	2 / 22 (9.09%)	1 / 20 (5.00%)
occurrences all number	2	1
Gastrointestinal disorders
Nausea
subjects affected / exposed	6 / 22 (27.27%)	6 / 20 (30.00%)
occurrences all number	7	8
Abdominal distension
subjects affected / exposed	4 / 22 (18.18%)	3 / 20 (15.00%)
occurrences all number	4	3
Constipation
subjects affected / exposed	4 / 22 (18.18%)	2 / 20 (10.00%)
occurrences all number	6	4
Vomiting
subjects affected / exposed	4 / 22 (18.18%)	3 / 20 (15.00%)
occurrences all number	4	3
Abdominal pain
subjects affected / exposed	3 / 22 (13.64%)	0 / 20 (0.00%)
occurrences all number	4	0
Dyspepsia
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)
occurrences all number	2	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)
occurrences all number	2	0
Musculoskeletal chest pain
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)
occurrences all number	2	0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	5 / 22 (22.73%)	0 / 20 (0.00%)
occurrences all number	11	0
Pruritus
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)
occurrences all number	3	0
Psychiatric disorders
Insomnia
subjects affected / exposed	3 / 22 (13.64%)	1 / 20 (5.00%)
occurrences all number	3	2
Anxiety
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)
occurrences all number	3	0
Renal and urinary disorders
Pollakiuria
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)
occurrences all number	3	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	3 / 22 (13.64%)	2 / 20 (10.00%)
occurrences all number	3	2
Muscle spasms
subjects affected / exposed	2 / 22 (9.09%)	1 / 20 (5.00%)
occurrences all number	2	1
Muscle twitching
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)
occurrences all number	2	0
Myalgia
subjects affected / exposed	2 / 22 (9.09%)	1 / 20 (5.00%)
occurrences all number	2	1
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	3 / 22 (13.64%)	4 / 20 (20.00%)
occurrences all number	3	5

More information

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Were there any global substantial amendments to the protocol? Yes

18 Jun 2012

Amendment 1 was issued in the UK before any subjects were enrolled in the study. The purpose of this amendment was to address revisions requested by the Medicines and Healthcare products Regulatory Agency regarding inclusion of assessments for serotonin syndrome.

24 Jul 2012

Amendment 1 version 1.1 was issued to all study sites, except those in the UK, before any subjects were enrolled in the study. The primary purpose of Amendment 1 version 1.1 was to revise the dose of INCB024360 from 400 mg to 600 mg BID, provide an updated summary of the ongoing clinical experience to justify the change in dose, and provide clarifications regarding eligibility, dose interruption and duration, PK sampling, and the survival follow-up schedule.

07 Sep 2012

The primary purpose of Amendment 1 version 1.2 was the same as Amendment 1 version 1.1 (to bring the sites in the UK up to date with the change in the dose of INCB024360 from 400 mg BID to 600 mg BID). All of the clinically important changes noted for Amendment 1 version 1.1 were noted for Amendment 1 version 1.2. Additional changes that were UK-specific to Amendment 1 version 1.2 included: • The definition of CA 125 elevation was revised to require screening CA 125 values of ≥ 2 × ULN on 2 occasions at least 1 week apart. • The protocol was revised to include the current CA 125 definitions agreed by GCIG in November 2005.

04 Feb 2013

Amendment 2 The primary purpose of this amendment is to revise eligibility criteria, add guidance for missed dosing, allow subjects more than one opportunity for screening, update regions for pharmacodynamic sample collection, and incorporate UK-specific Protocol requirements into the Protocol for all participating sites.

31 Oct 2013

Amendment 3 The primary purpose of this amendment is to allow subjects with Stage IC and II ovarian cancer to participate in this study and to include the option for subjects to have prescreening CA 125 monitoring.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
23 Oct 2014	Study was terminated by the sponsor for lack of evidence of superiority and slow study accrual.	-

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

No significant safety issues were identified during the Phase 1 or Phase 2 monotherapy programs. Development for this indication was terminated by the sponsor for lack of evidence of superiority and slow study accrual.

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