An Open Label Study to Evaluate G17DT Compared to Gemcitabine

Study Overview
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Brief Summary
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In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.

Official Title
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A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: G17DT
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent. A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection. Male or female patients over 18 years of age. Laboratory values within the following ranges at screening: Serum creatinine < 1.25 times upper limit of normal (ULN) Haemoglobin > 9.5 g/dL White blood cell (WBC) count > 3.5 x 109/L Platelets > 100 x 109/L Total bilirubin < 2.0 times ULN Aspartate transaminase (AST, SGOT) < 3 times ULN A life expectancy of at least 2 months. A negative pregnancy test at the screening visit (females of childbearing potential only). Signed written informed consent. Exclusion Criteria: History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix). Previous cytotoxic chemotherapy (including gemcitabine). Previous radiotherapy within 30 days of baseline. Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted. Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study. Participation in another study involving an investigational drug within 90 days of baseline.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, open, parallel group, active comparator
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G17DT<br>250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24. | Biological: G17DT<br>* 250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.<br>* Other names: PAS, Polyclonal Antibody Stimulator;|
| Active Comparator: Gemcitabine<br>1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest. | Drug: Gemcitabine<br>* 1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival in days measured starting at Baseline | Baseline (Week 0) up to Week 52 or death. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response | The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST). (RECIST) guidelines | Weeks 0, 12, 24, 36 and 52 | 
| Quality of Life | Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire | Weeks 0, 6, 12, 24, 36 and 52 | 
| Quality of Life | Quality of life measured using and the EORTC QLQ-PAN26 questionnaire | Weeks 0, 6, 12, 24, 36 and 52 | 
| Karnofsky Performance Status | Functional impairment assessment using the Karnofsky Performance Scale Index | Week 0 to Week 52 | 
| Gastrin-17 Antibodies | Antibody assessment to determine serum levels of Gastrin -17 antibodies | Weeks 0, 6, 12, 24, 36 and 52 |