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.
18 Years
N/A
Both
Pancreas Cancer
Trial Information
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.
(A few general items required)
Inclusion Criteria:
- 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 Criteria:
- Metastatic pancreas cancer patients post-resection
- Patients with no product-related ras mutation.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Recurrence free time and survival
Outcome Time Frame:
5 years
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
GI-4000-02
NCT ID:
NCT00300950
Start Date:
January 2006
Completion Date:
December 2014
Related Keywords:
- Pancreas Cancer
- Pancreas Cancer
- resected pancreas cancer
- non-metastatic pancreas cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| University of California San Diego | La Jolla, California 92093 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Tyler Cancer Center | Tyler, Texas 75702 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Tower Cancer Research Foundation | Beverly Hills, California 90211 |
| UCLA Medical Center | Los Angeles, California 90095-7059 |
| Ohio State University | Columbus, Ohio 43210 |
| Washington University | St. Louis, Missouri 63110 |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina |
| Texas Oncology, PA | Dallas, Texas 75246-2006 |
| South Texas Oncology & Hematology | San Antonio, Texas 78207 |
| Minnesota Oncology Hematology, PA | Minneapolis, Minnesota 55404 |
| Georgetown University Medical Center / Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Rush University Medical School | Chicago, Illinois 60612 |
| State University of NY at Stony Brook | Stony Brook, New York 11794 |
| The Texas Cancer Center Dallas Southwest | Dallas, Texas 75237 |
| Froedtert Multi-Disciplinary Cancer Clinic | Milwaukee, Wisconsin 53226 |
