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
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|ClinicalTrials.gov Identifier: NCT01280565|
Recruitment Status : Unknown
Verified October 2015 by AB Science.
Recruitment status was: Recruiting
First Posted : January 21, 2011
Last Update Posted : October 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: masitinib Drug: Dacarbazine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2017|
masitinib 7.5 mg/kg/day
|Active Comparator: dacarbazine||
dacarbazine IV bolus at 1,000 mg/m2 once every three weeks
- Overall Progression Free Survival (PFS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until progression or death ]
- Overall Survival (OS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280565
|Contact: Jean-Jacques GROB, MD, PhD||+33 (0)4 91 74 47 firstname.lastname@example.org|
|Hôpital Sainte Marguerite||Recruiting|
|Marseille, France, 13274|
|Contact: Jean-Jacques GROB, MD, PhD|