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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00300950

Enrollment

176

Registered

2006-03-10

Start date

2006-01-31

Completion date

2015-02-28

Last updated

2015-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer

Keywords

Pancreas Cancer, resected pancreas cancer, non-metastatic pancreas cancer

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.

Interventions

BIOLOGICALGI-4000

Heat-killed yeast cell transfected with target ras mutation.

DRUGGemcitabine

Chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

(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.

Design outcomes

Primary

Measure	Time frame
Recurrence free time and survival	5 years

Countries

India, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026