Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.

Official Title
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A Prospective, Randomized, Double-blind, Placebo-controlled, Group Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer.

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: G17DT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease) Male or female subjects over 18 years of age Subjects with a life expectancy of at least 2 months KPS score of ≥60% Written informed consent Exclusion Criteria: Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic [i.e., oral or injected] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.) History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix Known immunodeficiency Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.) Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study Previous G17DT treatment Hematological indicators as follows: Hemoglobin <9.5 g/dL Neutrophils <2.0 × 109/L Platelets <100 × 109/L Any other condition or circumstance that might have the following results: Worsen if the subject participated in the study Reduce the subject's ability to comply with the protocol Confound the interpretation of the study results

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G17DT<br>250 µg administered at Weeks 0,1,3 and 24 by intramuscular injection, followed by additional injections (boosters) of 250 µg every 6 months at investigator's discretion. | Biological: G17DT<br> <br> |
| Placebo Comparator: Placebo<br>Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival | The vital status of each patient was followed until death or end of the study. | Up to week 134 | 
| Number of Participants with Serious and Non-Serious Adverse Events | Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit. | up to week 134 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response | Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography. | Weeks 24 and 52 |