Pancreas Cancer Clinical Trial
Official title:
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.
| Verified date | April 2015 |
| Source | GlobeImmune |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 176 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
(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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Indo American Cancer Hospital and Research Centre | Hyderabad | |
| India | KMC Hospital | Mangalore | |
| India | Govt Medical Colleg & Hospital | Nagpur | |
| India | Lake Shore Hospital & Research Centre | Nettoor, Cochin | |
| India | G B Pan Hospital & Maulana Azad Medical College | New Delhi | |
| India | Nizam's Institute of Medical Sciences | Panjagutta, Hyderaba | |
| India | PSG Hospitals | Peelamedu, Coimbatore | Tamil Nadu |
| India | Lifeline Multispecialty Hospital | Perungudi, Chennai | |
| India | Sri Ramchandra Medical College & Research Institute | Ponur, Chennai | Tamil Nadu |
| India | Regional Cancer Centre | Trivandrum | |
| United States | Tower Cancer Research Foundation | Beverly Hills | California |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
| United States | Rush University Medical School | Chicago | Illinois |
| United States | Ohio State University | Columbus | Ohio |
| United States | Texas Oncology, PA | Dallas | Texas |
| United States | The Texas Cancer Center Dallas Southwest | Dallas | Texas |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | University of California San Diego | LaJolla | California |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | Froedtert Multi-Disciplinary Cancer Clinic | Milwaukee | Wisconsin |
| United States | Minnesota Oncology Hematology, PA | Minneapolis | Minnesota |
| United States | South Texas Oncology & Hematology | San Antonio | Texas |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | Washington University | St. Louis | Missouri |
| United States | State University of NY at Stony Brook | Stony Brook | New York |
| United States | Tyler Cancer Center | Tyler | Texas |
| United States | Georgetown University Medical Center / Lombardi Cancer Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| GlobeImmune |
United States, India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence free time and survival | 5 years | Yes |
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