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

Phase 3

Terminated

• Conditions: Metastatic Melanoma
• Interventions: Drug: Dacarbazine; Drug: Masitinib

• Registration Number: NCT01280565
• Lead Sponsor: AB Science

Brief 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.

Study Timeline

• Study First Submitted: 2010-08-06
• Study Start: 2011-01
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-21
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2019-12
• Disposition First Submitted: 2020-11-03
• Disposition First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Disposition First Posted: 2020-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dacarbazine	Dacarbazine	Participants receive dacarbazine, given via IV bolus at 1,000 mg/m2 once every 3 weeks. Following a protocol amendment, the dacarbarzine treatment group has been closed
Masitinib	Masitinib	Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	24 weeks	Estimated as the number of patients with documented partial response or complete response defined according to the RECIST criteria, divided by the number of randomized patients

Secondary Outcome Measures

Name	Time	Method
PFS	From day of randomization to disease progression or death, assessed for a maximum of 60 months	Progression Free Survival (PFS) is defined as the delay between the date of randomization to the date of documented progression (according to RECIST) or any cause of death during the study.
Overall Survival (OS)	From day of randomization to death, assessed for a maximum of 60 months	Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.

Trial Locations

Locations (9)

Blumenthal Cancer Centre; 🇺🇸 Charlotte, North Carolina, United States

Centre Hospitalier LE MANS; 🇫🇷 Le Mans, France

University Hospital Hradec Králové; 🇨🇿 Hradec Králové, Czechia

Hôpital Saint Andre; 🇫🇷 Bordeaux, France

Hôpital Sainte Marguerite; 🇫🇷 Marseille, France

Istituto Europeo di Oncologia; 🇮🇹 Milano, Italy

Klinik und Poliklinik für Hautkrankheiten; 🇩🇪 Münster, Germany

N.N.Blokhin Russian Cancer Research Centre; 🇷🇺 Moscow, Russian Federation

Hospital General de Valencia; 🇪🇸 Valencia, Spain