NCT01746979 - Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma | Biotech Hunter

Enrollment

693

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

February 29, 2016

Study Completion Date

May 31, 2016

Conditions

Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Interventions

DRUG

TH-302

TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

DRUG

Gemcitabine

Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

DRUG

Placebo (5 percent dextrose - D5W)

TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Trial Locations (2)

Unknown

Please Contact U.S. Medical Information, Rockland

Please Contact Merck Communication Center, Darmstadt