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| Sponsored by: |
GlobeImmune |
| Information provided by: | GlobeImmune |
| ClinicalTrials.gov Identifier: | NCT00300950 |
Purpose
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.
| Condition | Intervention | Phase |
|
Pancreas Cancer |
Biological: GI-4000 |
Phase II |
| MedlinePlus related topics: | Cancer Pancreatic Cancer |
| ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Pancrelipase Ultrase |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| 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. |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
(A few general items required)
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John Ferraro | 303-625-2733 |
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Show 43 Study Locations |
| GlobeImmune |
More Information
Sponsor website 
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| Study ID Numbers: | GI-4000-02 |
| First Received: | March 8, 2006 |
| Last Updated: | April 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00300950 |
| Health Authority: | United States: Food and Drug Administration |
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