Clinical trialPhase 3Unknown
A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients
A Prospective, Randomized, Open-label, Multicenter, Parallel Design, Phase III Study to Assess the Efficacy and Safety of GV1001 Concurrent With Gemcitabine/Capecitabine Versus Gemcitabine/Capecitabine Alone in Treating Locally Advanced and Metastatic Pancreatic Cancer Patients
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Unknown
- Study type
- Interventional
- Start
- November 2015
- Expected end
- May 2018
- Enrollment
- 148 participants
- Sites
- 16
- Primary outcomes
- Overall Survival
- Sponsor
- Industry
- Results posted
- No
- Last update
- 22 November 2016
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Brief summary public domain (ClinicalTrials.gov)
To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.
Detailed description public domain (ClinicalTrials.gov)
This study is designed as a phase III, prospective, randomized, open-label, multicenter clinical trial comparing GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in treating locally advanced and metastatic pancreatic cancer patients. Patients will be treated until disease progression and will be subject to follow-up until death. Patients will be randomized equally between the two arms: 1. Gemcitabine and Capecitabine 2. GV1001+ Gemcitabine and Capecitabine