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

Sponsor
AB Science (Industry)
Overall Status
Terminated
CT.gov ID
NCT01280565
Collaborator
(none)
134
9
2
103
14.9
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Masitinib

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

Drug: Masitinib
Masitinib 7.5 mg/kg/day
Other Names:
  • AB1010
  • Active Comparator: 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

    Drug: Dacarbazine
    IV bolus at 1,000 mg/m2 once every 3 weeks
    Other Names:
  • DTIC
  • Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate [24 weeks]

      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

    Secondary Outcome Measures

    1. PFS [From day of randomization to disease progression or death, assessed for a maximum of 60 months]

      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.

    2. Overall Survival (OS) [From day of randomization to death, assessed for a maximum of 60 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Blumenthal Cancer Centre Charlotte North Carolina United States 28204
    2 University Hospital Hradec Králové Hradec Králové Czechia 500 12
    3 Hôpital Saint Andre Bordeaux France 33075
    4 Centre Hospitalier LE MANS Le Mans France 72037
    5 Hôpital Sainte Marguerite Marseille France 13274
    6 Klinik und Poliklinik für Hautkrankheiten Münster Germany 48149
    7 Istituto Europeo di Oncologia Milano Italy 20141
    8 N.N.Blokhin Russian Cancer Research Centre Moscow Russian Federation 115478
    9 Hospital General de Valencia Valencia Spain 46014

    Sponsors and Collaborators

    • AB Science

    Investigators

    • Principal Investigator: Jean-Jacques GROB, MD, PhD, Hôpital Sainte Marguerite, Marseille, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AB Science
    ClinicalTrials.gov Identifier:
    NCT01280565
    Other Study ID Numbers:
    • AB08026
    First Posted:
    Jan 21, 2011
    Last Update Posted:
    Nov 5, 2020
    Last Verified:
    Dec 1, 2019
    Keywords provided by AB Science
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 5, 2020