Back to resultsSingle Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
Primary Purpose
Jaundice, 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 Jaundice
Eligibility Criteria
Inclusion Criteria:
- Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
- If patients were jaundiced, bilirubin had to be >80 μmol/L.
- Male or female patients over 18 years of age.
- World Health Organization (WHO) performance status of 0 to 2.
- Patients with a life expectancy of at least 8 weeks.
- Patients must have given written informed consent.
Exclusion Criteria:
- Patients undergoing a potentially curative resection.
- Jaundiced patients with a bilirubin value <80 μmol/L.
- Patients not considered fit for endoscopic or percutaneous biliary stenting.
- Patients receiving any other anti-cancer therapy.
- History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
- Females who were pregnant, planning to become pregnant, or who were lactating.
- Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.
- Previous G17DT treatment.
- Haematological indicators:
Haemoglobin (Hb) <10.0 g/dL. White cell count (WCC) <4.0×109/L. Platelets <100×109/L.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.
Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L.
Outcomes
Primary Outcome Measures
Pharmacodynamic
Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.
Patient Survival
The vital status of patients was monitored throughout the study and was followed until death or the end of the study.
Secondary Outcome Measures
Injection Tolerability
Tolerability was assessed by injection site during first 16 weeks after the first injection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02098239
Brief Title
Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
Official Title
An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
May 2002 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
5. Study Description
Brief Summary
The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.
Detailed Description
Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L.
Intervention Type
Drug
Intervention Name(s)
G17DT
Other Intervention Name(s)
Polyclonal Antibody Stimulator (PAS)
Primary Outcome Measure Information:
Title
Pharmacodynamic
Description
Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.
Time Frame
Weeks 0, 1,3,4,6,8,12, 16+
Title
Patient Survival
Description
The vital status of patients was monitored throughout the study and was followed until death or the end of the study.
Time Frame
Up to week 139
Secondary Outcome Measure Information:
Title
Injection Tolerability
Description
Tolerability was assessed by injection site during first 16 weeks after the first injection.
Time Frame
Up to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.
If patients were jaundiced, bilirubin had to be >80 μmol/L.
Male or female patients over 18 years of age.
World Health Organization (WHO) performance status of 0 to 2.
Patients with a life expectancy of at least 8 weeks.
Patients must have given written informed consent.
Exclusion Criteria:
Patients undergoing a potentially curative resection.
Jaundiced patients with a bilirubin value <80 μmol/L.
Patients not considered fit for endoscopic or percutaneous biliary stenting.
Patients receiving any other anti-cancer therapy.
History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.
Females who were pregnant, planning to become pregnant, or who were lactating.
Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.
Previous G17DT treatment.
Haematological indicators:
Haemoglobin (Hb) <10.0 g/dL. White cell count (WCC) <4.0×109/L. Platelets <100×109/L.
12. IPD Sharing Statement
Learn more about this trial
Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
We'll reach out to this number within 24 hrs