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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by AB Science
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT01280565
First received: August 6, 2010
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Metastatic Melanoma
Drug: masitinib
Drug: Dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AB Science:

Primary Outcome Measures:
  • Overall Progression Free Survival (PFS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until progression or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until death ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: masitinib Drug: masitinib
masitinib 7.5 mg/kg/day
Active Comparator: dacarbazine Drug: Dacarbazine
dacarbazine IV bolus at 1,000 mg/m2 once every three weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with histologically or cytologically confirmed non-resectable or metastatic stage 3 (non-resectable IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4 melanoma
  • Patient with detectable c-kit JM mutation confirmed by DNA or RNA sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin surrounding their primary melanoma)
  • Patient with measurable disease according to RECIST
  • Patient with ECOG ≤ 2

Exclusion Criteria:

  • Patient with other malignancies from which the patient has been continuously disease-free for < 3 years, with the exception of melanoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer, ductal or lobular carcinoma in situ of the breast
  • Patient with active brain metastases are not eligible. Patients with treated brain metastases are eligible if :

    • presence of 3 brain lesions or less
    • lesion(s) diameter is ≤ 2 cm
    • radiation therapy (gamma knife) was completed ≥ 4 weeks prior to baseline
    • surgery was completed ≥4 weeks prior to baseline
    • lesions assessed by follow-up scan (or MRI if MRI performed before brain therapy) ≥ 1 month after brain therapy are considered under control at baseline
  • Patient refractory to dacarbazine defined as patient presenting a disease progression after 3 months of dacarbazine therapy.
  • Prior treatment with a tyrosine kinase c-kit inhibitor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280565

Contacts
Contact: Jean-Jacques GROB, MD, PhD +33 (0)4 91 74 47 14 jean-jacques.grob@mail.ap-hm.fr

Locations
France
Hôpital Sainte Marguerite Recruiting
Marseille, France, 13274
Contact: Jean-Jacques GROB, MD, PhD         
Sponsors and Collaborators
AB Science
  More Information

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01280565     History of Changes
Other Study ID Numbers: AB08026
Study First Received: August 6, 2010
Last Updated: September 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AB Science:
non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014