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

• Status: Terminated
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science
• Treatments: Dacarbazine

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