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

Trial Profile

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

Completed
Phase of Trial: Phase II

Latest Information Update: 08 Apr 2015

At a glance

  • Drugs GI 4000 (Primary) ; Gemcitabine
  • Indications Pancreatic cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors GlobeImmune
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 05 Apr 2015 Planned End Date changed from 1 May 2015 to 1 Feb 2015 as reported by ClinicalTrials.gov record.
    • 05 Apr 2015 Planned primary completion date changed from 1 Mar 2015 to 1 Feb 2015 as reported by ClinicalTrials.gov record.
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