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Clinical Trial Results:
A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) with or without T-ChOSTM as adjuvant therapy in patients with surgically resected pancreatic cancer

Summary
EudraCT number	2014-001163-12
Trial protocol	DK
Global end of trial date	10 Jul 2018

Results information
Results version number	v1(current)
This version publication date	11 Sep 2020
First version publication date	11 Sep 2020
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

GI1604

ISRCTN number

US NCT number

NCT02767752

WHO universal trial number (UTN)

Sponsor organisation name

Herlev University Hospital, Oncology Dept.

Sponsor organisation address

Herlev Ringvej 75, Herlev, Denmark, 2730

Public contact

Herlev University Hospital, Oncolog Dept, Herlev University Hospital, Oncology Dept., 0045 38682344, dorte.nielsen.01@regionh.dk

Scientific contact

Herlev University Hospital, Oncology Dept, Herlev University Hospital, Oncology Dept., 0045 38682344, dorte.nielsen.01@regionh.dk

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

31 Jul 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

10 Jul 2018

Was the trial ended prematurely?

Yes

Main objective of the trial

Disease-free survival (DFS), defined as the time from the date of randomization to the date of disease recurrence determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, whichever is earlier.

Protection of trial subjects

Patients with informed consent and fulfilling eligibility criteria were included. Continues monitoring of standard safety parameters during treatment.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Jun 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Denmark: 25

Worldwide total number of subjects

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

The trial was opened for recruitment in December 2016 and prematurely closed for recruitment in July 2018 as modified FOLFIRINOX replaced GEM/CAP as standard of care for fit patients such as the target population for this trial. Recruitment at single site, Herlev University Hospital, Denmark

Screening details

Eligible patients were 18 years of age or older with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Time from resection to treatment start <=12 weeks. Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma was an exclusion criterion.

Number of subjects started

Intermediate milestone: Number of subjects

Screening: 25

Number of subjects completed

Reason: Number of subjects

screen failure (recurrent/disseminated disease): 4

Period 1 title

Treatment (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject, Monitor

Are arms mutually exclusive

Yes

Placebo

Arm description

Backbone chemotherapy (gemcitabine / capecitabine) + Placebo

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

600 mg daily for continuous oral intake until recurrence of disease

Investigational medicinal product name

Gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

1000 mg/m² on day 1, day 8 and day 15 of every 28-days cycle (total of 6 cycles)

Investigational medicinal product name

Capecitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

capecitabine 830 mg/m² twice daily for 21 days out of the 28 days of a treatment cycle (total of 6 cycles)

T-ChOS

Arm description

Backbone chemotherapy (gemcitabine/capecitabine) + T-ChOs

Arm type

Experimental

Investigational medicinal product name

T-ChOS

Investigational medicinal product code

Other name

Benecta

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

600 mg daily for continuous oral intake until recurrence of disease

Investigational medicinal product name

Gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

1000 mg/m² on day 1, day 8 and day 15 of every 28-days cycle (total of 6 cycles)

Investigational medicinal product name

Capecitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

capecitabine 830 mg/m² twice daily for 21 days out of the 28 days of a treatment cycle (total of 6 cycles)

Number of subjects in period 1 ^[1]	Placebo	T-ChOS
Started	12	9
Completed	1	9
Not completed	11	0
Unblinding at premature termination	6	-
Adverse event, non-fatal	5	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: In total, 25 patients signed consent and where screened (pre-assignment period). Of those, 21 patients were eventually enrolled (treatment period) and 4 patients were screen failures (did not complete pre-assignment period)

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Backbone chemotherapy (gemcitabine / capecitabine) + Placebo

Reporting group title

T-ChOS

Reporting group description

Backbone chemotherapy (gemcitabine/capecitabine) + T-ChOs

Reporting group values	Placebo	T-ChOS	Total
Number of subjects	12	9	21
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
median (full range (min-max))	71 (59 to 80)	68 (61 to 72)	-
Gender categorical
Units: Subjects
Female	6	6	12
Male	6	3	9
ECOG Performance status
Units: Subjects
ECOG 0	10	6	16
ECOG 1	2	3	5
Resection status
Units: Subjects
R0	9	7	16
R1	3	2	5
Nodal status
Units: Subjects
LN+	9	8	17
LN-	3	1	4

End points

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Reporting group title

Placebo

Reporting group description

Backbone chemotherapy (gemcitabine / capecitabine) + Placebo

Reporting group title

T-ChOS

Reporting group description

Backbone chemotherapy (gemcitabine/capecitabine) + T-ChOs

Primary: Disease Free Survival

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End point title

Disease Free Survival

End point description

End point type

Primary

End point timeframe

measured as the time from randomization to date of local tumor recurrence, lymph node spread, distant metastases, or death from any cause.

End point values	Placebo	T-ChOS
Number of subjects analysed	12	9
Units: months
median (confidence interval 95%)	8.4 (0 to 21.5)	10.8 (5.9 to 15.7)

primary endpoint

Comparison groups

Placebo v T-ChOS

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.57

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

1.34

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

3.69

Secondary: Overall Survival

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End point title

Overall Survival

End point description

End point type

Secondary

End point timeframe

Time from randomisation to death

End point values	Placebo	T-ChOS
Number of subjects analysed	12 ^[1]	9
Units: months
median (confidence interval 95%)	31.3 (0 to 99)	33.9 (22.3 to 45.6)

Notes
[1] - The CI in this group is not calculatable at time of analyse

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

from signed Informed consent to 30 days after treatment stop

Assessment type

Systematic

Dictionary name

NCI-CTCAE

Dictionary version

Reporting group title

Placebo

Reporting group description

Backbone chemotherapy (gemcitabine / capecitabine) + Placebo

Reporting group title

T-ChOS

Reporting group description

Backbone chemotherapy (gemcitabine/capecitabine) + T-ChOs

Serious adverse events	Placebo	T-ChOS
Total subjects affected by serious adverse events
subjects affected / exposed	9 / 12 (75.00%)	3 / 9 (33.33%)
number of deaths (all causes)	6	5
number of deaths resulting from adverse events	0	0
Vascular disorders
Pulmonary embolism
subjects affected / exposed	2 / 12 (16.67%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Chest pain
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebral infarction
subjects affected / exposed	1 / 12 (8.33%)	1 / 9 (11.11%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Fever
subjects affected / exposed	4 / 12 (33.33%)	1 / 9 (11.11%)
occurrences causally related to treatment / all	3 / 4	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Edema limbs
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Febrile neutropenia
subjects affected / exposed	2 / 12 (16.67%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	2 / 12 (16.67%)	1 / 9 (11.11%)
occurrences causally related to treatment / all	1 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Volvulus
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumonitis
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Skin infection
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary tract infection
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hyperglycaemia
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Placebo	T-ChOS
Total subjects affected by non serious adverse events
subjects affected / exposed	12 / 12 (100.00%)	9 / 9 (100.00%)
Vascular disorders
Thrombophlebitis
subjects affected / exposed	1 / 12 (8.33%)	1 / 9 (11.11%)
occurrences all number	1	1
General disorders and administration site conditions
Fatigue
subjects affected / exposed	8 / 12 (66.67%)	6 / 9 (66.67%)
occurrences all number	9	11
Flu-like symptoms
subjects affected / exposed	2 / 12 (16.67%)	0 / 9 (0.00%)
occurrences all number	2	0
common cold
subjects affected / exposed	0 / 12 (0.00%)	2 / 9 (22.22%)
occurrences all number	0	2
Fever
subjects affected / exposed	3 / 12 (25.00%)	2 / 9 (22.22%)
occurrences all number	3	3
Pain
subjects affected / exposed	2 / 12 (16.67%)	3 / 9 (33.33%)
occurrences all number	4	4
Edema limbs
subjects affected / exposed	2 / 12 (16.67%)	2 / 9 (22.22%)
occurrences all number	2	2
Injection site reaction
subjects affected / exposed	2 / 12 (16.67%)	0 / 9 (0.00%)
occurrences all number	2	0
Weight loss
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	1
Respiratory, thoracic and mediastinal disorders
Pneumonitis
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	1
Investigations
Neutropenia
subjects affected / exposed	8 / 12 (66.67%)	7 / 9 (77.78%)
occurrences all number	14	26
Thrombocytopenia
subjects affected / exposed	2 / 12 (16.67%)	4 / 9 (44.44%)
occurrences all number	3	8
Cardiac disorders
Chest pain
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences all number	1	0
Nervous system disorders
Cerebral infarction
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences all number	1	0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 12 (16.67%)	3 / 9 (33.33%)
occurrences all number	3	4
Febrile neutropenia
subjects affected / exposed	2 / 12 (16.67%)	0 / 9 (0.00%)
occurrences all number	2	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	7 / 12 (58.33%)	6 / 9 (66.67%)
occurrences all number	7	10
Nausea
subjects affected / exposed	5 / 12 (41.67%)	5 / 9 (55.56%)
occurrences all number	8	8
Vomiting
subjects affected / exposed	3 / 12 (25.00%)	2 / 9 (22.22%)
occurrences all number	4	3
Anorexia
subjects affected / exposed	7 / 12 (58.33%)	4 / 9 (44.44%)
occurrences all number	11	8
Mucositis oral
subjects affected / exposed	7 / 12 (58.33%)	5 / 9 (55.56%)
occurrences all number	13	9
Hemorrhoids
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences all number	1	0
Meteorism
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	9 / 12 (75.00%)	7 / 9 (77.78%)
occurrences all number	22	18
Rash
subjects affected / exposed	4 / 12 (33.33%)	1 / 9 (11.11%)
occurrences all number	4	1
Pruritus
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	1
Dry skin
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	1
Alopecia
subjects affected / exposed	0 / 12 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	1
Wound
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences all number	1	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	1 / 12 (8.33%)	0 / 9 (0.00%)
occurrences all number	1	0
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	1 / 12 (8.33%)	1 / 9 (11.11%)
occurrences all number	1	1
Infections and infestations
Infections
subjects affected / exposed	5 / 12 (41.67%)	4 / 9 (44.44%)
occurrences all number	8	6
Metabolism and nutrition disorders
Hypokalaemia
subjects affected / exposed	1 / 12 (8.33%)	1 / 9 (11.11%)
occurrences all number	1	1

More information

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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.

premature termination of recruitment - due to change in SOC, only 21 out of 180 planned patients included at that time

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Clinical trials

Clinical Trial Results:
A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) with or without T-ChOSTM as adjuvant therapy in patients with surgically resected pancreatic cancer

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Disease Free Survival

Primary: Disease Free Survival

Secondary: Overall Survival

Secondary: Overall Survival

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) with or without T-ChOSTM as adjuvant therapy in patients with surgically resected pancreatic cancer

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Disease Free Survival

Primary: Disease Free Survival

Secondary: Overall Survival

Secondary: Overall Survival

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) with or without T-ChOSTM as adjuvant therapy in patients with surgically resected pancreatic cancer