An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: G17DT

• Registration Number: NCT02098291
• Lead Sponsor: Cancer Advances Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04
• Primary Completion: 2001-07
• Study Completion: 2002-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-26
• Last Update Submitted: 2014-03-26
• Study First Posted: 2014-03-28
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
G17DT	G17DT	-

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic	Up to week 16	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

Name	Time	Method
Patient Survival	Up to week 139	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	Up to week 60	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.