Back to resultsAn Open Label Study to Evaluate G17DT Compared to Gemcitabine
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
G17DT
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
G17DT
Gemcitabine
Arm Description
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
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.
Outcomes
Primary Outcome Measures
Survival
Survival in days measured starting at Baseline
Secondary Outcome Measures
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
Quality of Life
Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire
Quality of Life
Quality of life measured using and the EORTC QLQ-PAN26 questionnaire
Karnofsky Performance Status
Functional impairment assessment using the Karnofsky Performance Scale Index
Gastrin-17 Antibodies
Antibody assessment to determine serum levels of Gastrin -17 antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03200821
Brief Title
An Open Label Study to Evaluate G17DT Compared to Gemcitabine
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 14, 2000 (Actual)
Primary Completion Date
September 24, 2001 (Actual)
Study Completion Date
September 19, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
Interventional Study Model
Parallel Assignment
Model Description
A randomized, open, parallel group, active comparator
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G17DT
Arm Type
Experimental
Arm Description
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
G17DT
Other Intervention Name(s)
PAS, Polyclonal Antibody Stimulator
Intervention Description
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival
Description
Survival in days measured starting at Baseline
Time Frame
Baseline (Week 0) up to Week 52 or death.
Secondary Outcome Measure Information:
Title
Tumor Response
Description
The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST).
(RECIST) guidelines
Time Frame
Weeks 0, 12, 24, 36 and 52
Title
Quality of Life
Description
Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire
Time Frame
Weeks 0, 6, 12, 24, 36 and 52
Title
Quality of Life
Description
Quality of life measured using and the EORTC QLQ-PAN26 questionnaire
Time Frame
Weeks 0, 6, 12, 24, 36 and 52
Title
Karnofsky Performance Status
Description
Functional impairment assessment using the Karnofsky Performance Scale Index
Time Frame
Week 0 to Week 52
Title
Gastrin-17 Antibodies
Description
Antibody assessment to determine serum levels of Gastrin -17 antibodies
Time Frame
Weeks 0, 6, 12, 24, 36 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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An Open Label Study to Evaluate G17DT Compared to Gemcitabine
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