NCT00300950

Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer

A Phase 2 Double-Blind, Placebo Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a Gemcitabine Regimen With Placebo, in Patients With Post-resection R0/R1 Pancreatic Cancer With Tumor Sequence Confirmation of Ras Mutations.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: GlobeImmune · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GI-4000	Heat-killed yeast cell transfected with target ras mutation.
DRUG	Gemcitabine	Chemotherapy

Timeline

• Start date: 2006-01-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2006-03-10
• Last updated: 2015-04-06

Locations

28 sites across 2 countries: United States, India