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

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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Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PSG Hospitals, Peelamedu, Coimbatore, Tamil Nadu, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

(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.

Treatment and study plan

GI-4000

Biological

Heat-killed yeast cell transfected with target ras mutation.

Gemcitabine

Drug

Chemotherapy

Primary outcomes

Recurrence free time and survival

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

GlobeImmune

Industry

Registry information

Official study 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.

Important dates

Study start: 2006
Primary completion: 2015
Study completion: 2015
First posted: Mar 10, 2006
Registry last updated: Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed