An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma (PC1)
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
G17DT
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
- Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
- Male or female patients over 18 years of age
- Patients with a life expectancy of at least 2 months
- Patients must have given written informed consent
- Patients with a Karnofsky Performance Status score of ≥ 50%
- Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)
Exclusion Criteria:
- History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
- Concomitant use or anticipated use in the period of the study of radiotherapy
- Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
- Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
- Females who were pregnant, planning to become pregnant or lactating
- Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
- Haematological indicators:
Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
G17DT
Arm Description
Outcomes
Primary Outcome Measures
Pharmacodynamic
Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.
Secondary Outcome Measures
Patient Survival
The vital status was monitored throughout the study and was followed up to the death of the last patient.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02098291
Brief Title
An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
Acronym
PC1
Official Title
Phase II, Open, Single-center Study to Determine the Antibody Response to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
February 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
5. Study Description
Brief Summary
This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to 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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G17DT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
G17DT
Primary Outcome Measure Information:
Title
Pharmacodynamic
Description
Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.
Time Frame
Up to week 16
Secondary Outcome Measure Information:
Title
Patient Survival
Description
The vital status was monitored throughout the study and was followed up to the death of the last patient.
Time Frame
Up to week 139
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 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
Male or female patients over 18 years of age
Patients with a life expectancy of at least 2 months
Patients must have given written informed consent
Patients with a Karnofsky Performance Status score of ≥ 50%
Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)
Exclusion Criteria:
History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
Concomitant use or anticipated use in the period of the study of radiotherapy
Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
Females who were pregnant, planning to become pregnant or lactating
Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
Haematological indicators:
Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l
12. IPD Sharing Statement
Learn more about this trial
An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
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