Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer (PC6)
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
G17DT
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
G17DT
Placebo
Arm Description
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.
Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months.
Outcomes
Primary Outcome Measures
Patient Survival
The vital status of each patient was followed until death or end of the study.
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.
Secondary Outcome Measures
Objective tumor response
Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02118077
Brief Title
Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer
Acronym
PC6
Official Title
A Prospective, Randomized, Double-blind, Placebo-controlled, Group Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
5. Study Description
Brief Summary
Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G17DT
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months.
Intervention Type
Biological
Intervention Name(s)
G17DT
Primary Outcome Measure Information:
Title
Patient Survival
Description
The vital status of each patient was followed until death or end of the study.
Time Frame
Up to week 134
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
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.
Time Frame
up to week 134
Secondary Outcome Measure Information:
Title
Objective tumor response
Description
Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography.
Time Frame
Weeks 24 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer
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