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 - Tabular View

Tracking Information

First Received Date ^ICMJE

March 8, 2006

Last Updated Date

April 14, 2009

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Recurrence free time and survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00300950 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pancreas Cancer

Intervention ^ICMJE

Biological: GI-4000
Drug: Gemcitabine

Study Arms / Comparison Groups

Active Comparator: Gencitabine
Experimental: Gemcitabine with GI-4000

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

(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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: John Ferraro

303-625-2733

Location Countries ^ICMJE

United States, India

Administrative Information

NCT ID ^ICMJE

NCT00300950

Responsible Party

John Ferraro MBA Director Clinical Operations, GlobeImmune, Inc.

Study ID Numbers ^ICMJE

GI-4000-02

Study Sponsor ^ICMJE

GlobeImmune

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

GlobeImmune

Verification Date

April 2009

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