NCT02854072

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Samsung Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	GV1001	At week 1, GV1001 will be administered intradermally on day 1, day 3 and day 5. This will be followed by a once weekly schedule for weeks 2, 3, 4 and 6. After that, GV1001 will be administered once monthly until withdrawal from trial treatment due to patient choice, intolerable toxicity or disease progression. GM-CSF will be used as an adjuvant, given 10-15 minutes prior to each administration of GV1001.
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.
DRUG	Capecitabine	Capecitabine 830 mg/m\^2 will be orally given in the morning and evening (total dose of 1660 mg/m\^2) for 21 days followed by 7 days' rest.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2016-08-03
• Last updated: 2016-11-22

Locations

16 sites across 1 country: South Korea