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:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Phase 3 Study to Compare Efficacy and Safety of Masitinib 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
  • Official Title: A Prospective, Multicenter, Randomized, Open-label, Activecontrolled, 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
masitinibmasitinib
Dacarbazinedacarbazine

Purpose

Masitinib is a novel TKI that potently inhibits wild type (WT) c-kit and its activated form, mutated in the juxtamembrane region (JM c-kit) PDGFRs, the intracellular kinase Lyn, and to a lesser extent fibroblast growth factor receptor 3 (FGFR3). Pre-clinical data suggest that masitinib is a strong candidate for the treatment of patients with advanced melanoma carrying a c-kit JM mutation.

Trial Arms

NameTypeDescriptionInterventions
masitinibExperimental
  • masitinib
dacarbazineActive Comparator
  • Dacarbazine

Eligibility Criteria

        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 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 with measurable disease according to RECIST

          -  Patient with ECOG ≤ 2

        Exclusion Criteria:

          -  Patient with other malignancies from which the patient has been continuously
             disease-free for < 3 years, with the exception of melanoma, cervical carcinoma in
             situ, basal cell or squamous cell skin cancer, ductal or lobular carcinoma in situ of
             the breast

          -  Patient with active brain metastases are not eligible. Patients with treated brain
             metastases are eligible if :

               -  presence of 3 brain lesions or less

               -  lesion(s) diameter is ≤ 2 cm

               -  radiation therapy (gamma knife) was completed ≥ 4 weeks prior to baseline

               -  surgery was completed ≥4 weeks prior to baseline

               -  lesions assessed by follow-up scan (or MRI if MRI performed before brain therapy)
                  ≥ 1 month after brain therapy are considered under control at baseline

          -  Patient refractory to dacarbazine defined as patient presenting a disease progression
             after 3 months of dacarbazine therapy.

          -  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:Overall Progression Free Survival (PFS)
Time Frame:at week 6, 12, 18, 24 and every 12 weeks until progression or death
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:at week 6, 12, 18, 24 and every 12 weeks until death
Safety Issue:
Description:

Details

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

Trial Keywords

  • non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit

Last Updated

October 7, 2015