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

Completed
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
  • 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
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top