Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma

Phase 2 Completed 214 enrolled ImmunoGenesis PRA Health Sciences · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302 are effective in the treatment of subjects with first-line metastatic pancreatic adenocarcinoma.

Timeline

Start: 2010-06
Primary completion: 2013-09
Completion: 2014-12

Outcome

Met primary endpoint

paper PFS was significantly longer with gemcitabine plus TH-302 (pooled combination arms) compared with gemcitabine alone PMID 25512461 ↗

Publications

Borad MJ, Reddy SG, Bahary N, Uronis HE, Sigal D, Cohn AL, Schelman WR, Stephenson J Jr, Chiorean EG, Rosen PJ, Ulrich B, Dragovich T, Del Prete SA, Rarick M, Eng C, Kroll S, Ryan DP. Randomized Phase II Trial of Gemcitabine Plus TH-302 Versus Gemcitabine in Patients With Advanced Pancreatic Cancer. J Clin Oncol. 2015 May 1;33(13):1475-81. doi: 10.1200/JCO.2014.55.7504. Epub 2014 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evofosfamide	Other / unclassified	240 mg/m2	Intravenous
Subject	Evofosfamide	Other / unclassified	340 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous