Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

Conditions
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Jaundice, Pancreatic Cancer

Intervention / Treatment
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* Drug: G17DT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting. | Drug: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator (PAS);|
| Active Comparator: Group B<br>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. | Drug: G17DT<br> <br> * Other names: Polyclonal Antibody Stimulator (PAS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic | Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit. | Weeks 0, 1,3,4,6,8,12, 16+ | 
| Patient Survival | The vital status of patients was monitored throughout the study and was followed until death or the end of the study. | Up to week 139 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection Tolerability | Tolerability was assessed by injection site during first 16 weeks after the first injection. | Up to Week 16 |