Melanoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

134

Study ID:

NCT01280565

Recruitment Status:

Terminated

Sponsor:

AB Science

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There are 9 Locations for this study

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Blumenthal Cancer Centre
Charlotte North Carolina, 28204, United States
University Hospital Hradec Králové
Hradec Králové , 500 1, Czechia
Hôpital Saint Andre
Bordeaux , 33075, France
Centre Hospitalier LE MANS
Le Mans , 72037, France
Hôpital Sainte Marguerite
Marseille , 13274, France
Klinik und Poliklinik für Hautkrankheiten
Münster , 48149, Germany
Istituto Europeo di Oncologia
Milano , 20141, Italy
N.N.Blokhin Russian Cancer Research Centre
Moscow , 11547, Russian Federation
Hospital General de Valencia
Valencia , 46014, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

134

Study ID:

NCT01280565

Recruitment Status:

Terminated

Sponsor:


AB Science

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