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Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit

NCT01280565 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2020-11-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Masitinib

Masitinib 7.5 mg/kg/day

DRUG

Dacarbazine

IV bolus at 1,000 mg/m2 once every 3 weeks

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Jean-Jacques GROB, MD, PhD · Hôpital Sainte Marguerite, Marseille, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Italy
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01280565 on ClinicalTrials.gov