Status:

COMPLETED

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

Lead Sponsor:

GlobeImmune

Conditions:

Pancreas Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 ...

Eligibility Criteria

Inclusion

  • (A few general items required)
  • Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation
  • \>18 years of age
  • Negative skin test for hypersensitivity to Saccharomyces cerevisiae

Exclusion

  • Metastatic pancreas cancer patients post-resection
  • Patients with no product-related ras mutation.

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2015

Estimated Enrollment :

176 Patients enrolled

Trial Details

Trial ID

NCT00300950

Start Date

January 1 2006

End Date

February 1 2015

Last Update

April 6 2015

Active Locations (28)

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Page 1 of 7 (28 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

Tower Cancer Research Foundation

Beverly Hills, California, United States, 90211

3

University of California San Diego

La Jolla, California, United States, 92093

4

UCLA Medical Center

Los Angeles, California, United States, 90095