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

NCT01280565 | Terminated Phase 3 DMC

• 1 other identifier: AB08026
• Study Type: interventional
• Target: 134
• Locations: 7 countries
• Sites: 9

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.

Conditions

Metastatic Melanoma

Keywords

Melanoma; Tyrosine kinase inhibitor; c-Kit juxta membrane mutation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PFS

  From day of randomization to disease progression or death, assessed for a maximum of 60 months

• Overall Survival (OS)

  From day of randomization to death, assessed for a maximum of 60 months

Study Arms (2)

Masitinib

EXPERIMENTAL

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

Drug: Masitinib

Dacarbazine

ACTIVE COMPARATOR

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

Drug: Dacarbazine

Interventions

Masitinib DRUG

Masitinib 7.5 mg/kg/day

Also known as: AB1010

Masitinib

Dacarbazine DRUG

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

Also known as: DTIC

Dacarbazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• AB Science: lead

Study Sites (9)

Blumenthal Cancer Centre

Charlotte, North Carolina, 28204, United States

Location

University Hospital Hradec Králové

Hradec Králové, 500 12, Czechia

Location

Hôpital Saint Andre

Bordeaux, 33075, France

Location

Centre Hospitalier LE MANS

Le Mans, 72037, France

Location

Hôpital Sainte Marguerite

Marseille, 13274, France

Location

Klinik und Poliklinik für Hautkrankheiten

Münster, 48149, Germany

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

N.N.Blokhin Russian Cancer Research Centre

Moscow, 115478, Russia

Location

Hospital General de Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Melanoma

Interventions

masitinib; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean-Jacques GROB, MD, PhD

  Hôpital Sainte Marguerite, Marseille, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: January 21, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 5, 2020

Record last verified: 2019-12

Locations

US (1); CZ (1); FR (3); ES (1); DE (1); IT (1); RU (1)