An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma (PC1)

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: G17DT

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G17DT	Drug: G17DT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survival	The vital status was monitored throughout the study and was followed up to the death of the last patient.	Up to week 139
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.	Up to week 60

Collaborators and Investigators

• Sponsor: Cancer Advances Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): July 1, 2001
• Study Completion (Actual): February 1, 2002

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 28, 2014

Study Record Updates

• Last Update Posted (Estimate): March 28, 2014
• Last Update Submitted That Met QC Criteria: March 26, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PC1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No