A prospective, multicenter, open-label, uncontrolled, two-parallel group, phase 1/2 study to evaluate safety and efficacy of masitinib at 9 mg/kg/day in monotherapy and in combination with dacarbazine in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma not carrying a mutation in the juxta membrane domain of c-kit
Phase of Trial: Phase I/II
Latest Information Update: 25 Jun 2015
At a glance
- Drugs Masitinib (Primary) ; Dacarbazine
- Indications Malignant melanoma
- Focus Therapeutic Use
- Sponsors AB Science
- 25 Jun 2015 According to an AB Science media release, this study did not pass the pre-planned statistical analysis to detect a superiority trend in overall survival between masitinib in combination with standard-of-care chemotherapy when compared against its relevant historical meta-analysis benchmark. Therefore, the indication will not be moved to phase III.
- 17 Jan 2015 According to the European Clinical Trials Database record, status changed from recruiting to completed.
- 20 Jun 2011 New trial record