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.
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
Interventions
Drug | Synonyms | Arms |
---|
masitinib | | masitinib |
Dacarbazine | | dacarbazine |
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
Name | Type | Description | Interventions |
---|
masitinib | Experimental | | |
dacarbazine | Active Comparator | | |
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