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.
1 other identifier
interventional
176
2 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2006
Longer than P75 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 8, 2006
CompletedFirst Posted
Study publicly available on registry
March 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 6, 2015
April 1, 2015
9.1 years
March 8, 2006
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence free time and survival
5 years
Study Arms (2)
1
ACTIVE COMPARATORGencitabine
2
EXPERIMENTALGemcitabine with GI-4000
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Metastatic pancreas cancer patients post-resection
- Patients with no product-related ras mutation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlobeImmunelead
Study Sites (28)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
University of California San Diego
La Jolla, California, 92093, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Georgetown University Medical Center / Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Rush University Medical School
Chicago, Illinois, 60612, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404, United States
Washington University
St Louis, Missouri, 63110, United States
State University of NY at Stony Brook
Stony Brook, New York, 11794, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Ohio State University
Columbus, Ohio, 43210, United States
Texas Oncology, PA
Dallas, Texas, 75231, United States
The Texas Cancer Center Dallas Southwest
Dallas, Texas, 75237, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
South Texas Oncology & Hematology
San Antonio, Texas, 78229, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Froedtert Multi-Disciplinary Cancer Clinic
Milwaukee, Wisconsin, 53226, United States
PSG Hospitals
Peelamedu, Coimbatore, Tamil Nadu, 641004, India
Sri Ramchandra Medical College & Research Institute
Ponur, Chennai, Tamil Nadu, 600116, India
Indo American Cancer Hospital and Research Centre
Hyderabad, 500034, India
KMC Hospital
Mangalore, 575001, India
Govt Medical Colleg & Hospital
Nagpur, India
Lake Shore Hospital & Research Centre
Nettoor, Cochin, 682304, India
G B Pan Hospital & Maulana Azad Medical College
New Delhi, 110002, India
Nizam's Institute of Medical Sciences
Panjagutta, Hyderaba, 500082, India
Lifeline Multispecialty Hospital
Perungudi, Chennai, 600096, India
Regional Cancer Centre
Trivandrum, 695011, India
Related Publications (1)
Muscarella P, Bekaii-Saab T, McIntyre K, Rosemurgy A, Ross SB, Richards DA, Fisher WE, Flynn PJ, Mattson A, Coeshott C, Roder H, Roder J, Harrell FE, Cohn A, Rodell TC, Apelian D. A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer. J Pancreat Cancer. 2021 Mar 23;7(1):8-19. doi: 10.1089/pancan.2020.0021. eCollection 2021.
PMID: 33786412DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2006
First Posted
March 10, 2006
Study Start
January 1, 2006
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 6, 2015
Record last verified: 2015-04