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

Phase 3TerminatedNCT01280565

AB Science134 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Metastatic Melanoma

Interventions

MasitinibDRUG

Masitinib 7.5 mg/kg/day

DacarbazineDRUG

IV bolus at 1,000 mg/m2 once every 3 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Main inclusion criteria include: * Patient with histologically or cytologically confirmed non-resectable or metastatic stage 3 (non-resectable IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4 melanoma * Patient with detectable c-Kit JM mutation (mutation in exon 9, 11 or 13) confirmed by DNA or RNA sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin surrounding their primary melanoma). * Patient not previously treated for melanoma (first-line) Main exclusion criteria include: * Pregnant, or nursing female patient * Patient with active brain metastases. * Prior treatment with a tyrosine kinase c-Kit inhibitor

Locations (9)

Blumenthal Cancer Centre

Charlotte, North Carolina, United States

University Hospital Hradec Králové

Hradec Králové, Czechia

Hôpital Saint Andre

Bordeaux, France

Centre Hospitalier LE MANS

Le Mans, France

Outcomes

Primary Outcomes

Objective Response Rate

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

Time frame: 24 weeks

Secondary Outcomes

PFS

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.

Time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months

Overall Survival (OS)

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.

Time frame: From day of randomization to death, assessed for a maximum of 60 months

Data from ClinicalTrials.gov

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