Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Phase 3 Completed 353 enrolled AB Science

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.

Timeline

Start: 2008-11-25
Primary completion: 2011-12-23
Completion: 2012-08-31

Outcome

Missed primary endpoint

paper hazard ratio (HR) of 0.89 (95% CI [0.70; 1.13]. PMID 25858497 ↗

Publications

Results Deplanque G, Demarchi M, Hebbar M, Flynn P, Melichar B, Atkins J, Nowara E, Moye L, Piquemal D, Ritter D, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Hammel P. A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer. Ann Oncol. 2015 Jun;26(6):1194-1200. doi: 10.1093/annonc/mdv133. Epub 2015 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Masitinib	Small molecule	9 mg/kg	Oral
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous