Clinical trialPhase 3Completed
Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- 25 November 2008
- Expected end
- 31 August 2012
- Enrollment
- 353 participants
- Sites
- 68
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 17 December 2018
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
Human pancreatic cancer overexpresses a number of important tyrosine kinase (TK) growth factors receptors and ligands, including expression of both PDGF and PDGF receptors. Drugs that can selectively inhibit TKs are likely to be of benefit in pancreatic cancer. Masitinib is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases. Pre-clinical and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor cell lines to gemcitabine. Based on pre-clinical and phase 2 clinical studies, masitinib can be considered as a good candidate to use in combination with gemcitabine in the treatment of pancreatic cancer.
Papers 1
- Registry-listed results paperA randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic … DOI 10.1093/annonc/mdv133↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.