Clinical trial NCT01280565: Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Melanoma
Keywords: Melanoma
Tyrosine kinase inhibitor
c-Kit juxta membrane mutation
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 24 weeks
Secondary outcomes:
measure: PFS
timeFrame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
measure: Overall Survival (OS)
timeFrame: From day of randomization to death, assessed for a maximum of 60 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Blumenthal Cancer Centre
state: North Carolina
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
city: Bordeaux
country: France
facility: Hôpital Saint Andre
city: Le Mans
country: France
facility: Centre Hospitalier LE MANS
city: Marseille
country: France
facility: Hôpital Sainte Marguerite
city: Münster
country: Germany
facility: Klinik und Poliklinik für Hautkrankheiten
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Moscow
country: Russian Federation
facility: N.N.Blokhin Russian Cancer Research Centre
city: Valencia
country: Spain
facility: Hospital General de Valencia
Study officials:
affiliation: Hôpital Sainte Marguerite, Marseille, France
name: Jean-Jacques GROB, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: