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

NCT ID: NCT01280565

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Metastatic Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Masitinib

Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.

Group Type EXPERIMENTAL

Masitinib

Intervention Type DRUG

Masitinib 7.5 mg/kg/day

Dacarbazine

Participants receive dacarbazine, given via IV bolus at 1,000 mg/m2 once every 3 weeks. Following a protocol amendment, the dacarbarzine treatment group has been closed

Group Type ACTIVE_COMPARATOR

Dacarbazine

Intervention Type DRUG

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

Interventions

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Masitinib

Masitinib 7.5 mg/kg/day

Intervention Type DRUG

Dacarbazine

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

Intervention Type DRUG

Other Intervention Names

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AB1010 DTIC

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Pregnant, or nursing female patient
* Patient with active brain metastases.
* Prior treatment with a tyrosine kinase c-Kit inhibitor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Jacques GROB, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Sainte Marguerite, Marseille, France

Locations

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Blumenthal Cancer Centre

Charlotte, North Carolina, United States

Site Status

University Hospital Hradec Králové

Hradec Králové, , Czechia

Site Status

Hôpital Saint Andre

Bordeaux, , France

Site Status

Centre Hospitalier LE MANS

Le Mans, , France

Site Status

Hôpital Sainte Marguerite

Marseille, , France

Site Status

Klinik und Poliklinik für Hautkrankheiten

Münster, , Germany

Site Status

Istituto Europeo di Oncologia

Milan, , Italy

Site Status

N.N.Blokhin Russian Cancer Research Centre

Moscow, , Russia

Site Status

Hospital General de Valencia

Valencia, , Spain

Site Status

Countries

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United States Czechia France Germany Italy Russia Spain

Other Identifiers

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AB08026

Identifier Type: -

Identifier Source: org_study_id