NCT01280565

Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit

A Prospective, Multicenter, Randomized, Open-label, Active Controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Dacarbazine in the Treatment of Patients With Non-resectable or Metastatic Stage 3 or Stage 4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of C-kit

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit and who have not previously been treated for melanoma.

Detailed description

Masitinib is a selective tyrosine kinase inhibitor with potent activity against the juxta membrane domain of c-Kit. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study was to evaluate the efficacy and safety of masitinib with respect to dacarbazine in the treatment of non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit. Following a protocol amendment, the dacarbarzine treatment group was closed and recruitment restricted to masitinib treatment of chemo-naïve (first-line) patients.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Masitinib	Masitinib 7.5 mg/kg/day
DRUG	Dacarbazine	IV bolus at 1,000 mg/m2 once every 3 weeks

Timeline

• Start date: 2011-01-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2011-01-21
• Last updated: 2020-11-05

Locations

9 sites across 7 countries: United States, Czechia, France, Germany, Italy, Russia, Spain