Clinical Trials /

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

NCT01280565

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Terminated

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT01280565

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: AB08026
  • NCT ID: NCT01280565

Conditions

  • Metastatic Melanoma

Interventions

DrugSynonymsArms
MasitinibAB1010Masitinib
DacarbazineDTICDacarbazine

Purpose

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

      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.

Trial Arms

NameTypeDescriptionInterventions
MasitinibExperimentalParticipants receive masitinib (7.5 mg/kg/day), given orally twice daily.
  • Masitinib
DacarbazineActive ComparatorParticipants 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
  • Dacarbazine

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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate
Time Frame:24 weeks
Safety Issue:
Description: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

Measure:PFS
Time Frame:From day of randomization to disease progression or death, assessed for a maximum of 60 months
Safety Issue:
Description: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.
Measure:Overall Survival (OS)
Time Frame:From day of randomization to death, assessed for a maximum of 60 months
Safety Issue:
Description: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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:AB Science

Trial Keywords

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

Last Updated

November 5, 2020