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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

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ClinicalTrials.gov Identifier: NCT00300950
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
GlobeImmune

March 8, 2006
March 10, 2006
April 6, 2015
January 2006
February 2015   (Final data collection date for primary outcome measure)
Recurrence free time and survival [ Time Frame: 5 years ]
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Complete list of historical versions of study NCT00300950 on ClinicalTrials.gov Archive Site
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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.
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.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pancreas Cancer
  • Biological: GI-4000
    Heat-killed yeast cell transfected with target ras mutation.
  • Drug: Gemcitabine
    Chemotherapy
  • Active Comparator: 1
    Gencitabine
    Intervention: Biological: GI-4000
  • Experimental: 2
    Gemcitabine with GI-4000
    Intervention: Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
100
February 2015
February 2015   (Final data collection date for primary outcome measure)

(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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
India,   United States
 
 
NCT00300950
GI-4000-02
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GlobeImmune
GlobeImmune
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GlobeImmune
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP