Metastatic Melanoma
Conditions
Keywords
Melanoma, Tyrosine kinase inhibitor, c-Kit juxta membrane mutation
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.
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.
Interventions
DRUGMasitinib
Masitinib 7.5 mg/kg/day
DRUGDacarbazine
IV bolus at 1,000 mg/m2 once every 3 weeks
Sponsors
AB Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Czechia, France, Germany, Italy, Russia, Spain, United States
Outcome results
None listed