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A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

Pancreatic Cancer Clinical Trial

Official title:
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

Clinical Trial Summary

To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02854072
Study type Interventional
Source Samsung Pharmaceutical Co., Ltd.
Contact Hanna Park
Email hpark@kaelgemvax.com
Status Recruiting
Phase Phase 3
Start date November 2015
Completion date May 2018
View Details
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