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

Metastatic Melanoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01280565
• Other study ID #: AB08026
• Status: Terminated
• Phase: Phase 3
• Start date: January 2011
• Est. completion date: August 2019

Study information

• Verified date: December 2019
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 134
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Masitinib
Masitinib 7.5 mg/kg/day
• Dacarbazine
IV bolus at 1,000 mg/m2 once every 3 weeks

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Králové	Hradec Králové
France	Hôpital Saint Andre	Bordeaux
France	Centre Hospitalier LE MANS	Le Mans
France	Hôpital Sainte Marguerite	Marseille
Germany	Klinik und Poliklinik für Hautkrankheiten	Münster
Italy	Istituto Europeo di Oncologia	Milano
Russian Federation	N.N.Blokhin Russian Cancer Research Centre	Moscow
Spain	Hospital General de Valencia	Valencia
United States	Blumenthal Cancer Centre	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Italy,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks
Secondary	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.	From day of randomization to disease progression or death, assessed for a maximum of 60 months
Secondary	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.	From day of randomization to death, assessed for a maximum of 60 months