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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Jun 2015

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At a glance

  • Drugs Masitinib (Primary) ; Dacarbazine
  • Indications Malignant melanoma
  • Focus Therapeutic Use
  • Sponsors AB Science
  • Most Recent Events

    • 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
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