Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: G17DT Immunogen

• Registration Number: NCT00044031
• Lead Sponsor: Cancer Advances Inc.

Brief Summary

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2002-08-16
• Study First Submitted QC: 2002-08-19
• Study First Posted: 2002-08-20
• Primary Completion: 2004-04
• Study Completion: 2007-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	G17DT Immunogen	500 µg G17DT immunogen combined with gemcitabine.

Primary Outcome Measures

Name	Time	Method
Survival	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Serious and Non-Serious Adverse Events	Up to 12 months	Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.