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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreas Cancer

Thank you

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 MedicineHouston, Texas  77030
University of California San DiegoLa Jolla, California  92093
Seattle Cancer Care AllianceSeattle, Washington  98109
Tyler Cancer CenterTyler, Texas  75702
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Tower Cancer Research FoundationBeverly Hills, California  90211
UCLA Medical CenterLos Angeles, California  90095-7059
Ohio State UniversityColumbus, Ohio  43210
Washington UniversitySt. Louis, Missouri  63110
UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  
Texas Oncology, PADallas, Texas  75246-2006
South Texas Oncology & HematologySan Antonio, Texas  78207
Minnesota Oncology Hematology, PAMinneapolis, Minnesota  55404
Georgetown University Medical Center / Lombardi Cancer CenterWashington, District of Columbia  20007
Rush University Medical SchoolChicago, Illinois  60612
State University of NY at Stony BrookStony Brook, New York  11794
The Texas Cancer Center Dallas SouthwestDallas, Texas  75237
Froedtert Multi-Disciplinary Cancer ClinicMilwaukee, Wisconsin  53226