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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by AB Science.
Recruitment status was  Recruiting
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

August 6, 2010
September 19, 2012
January 2011
December 2013   (final data collection date for primary outcome measure)
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 ]
Overall Progression Free Survival (PFS) [ Time Frame: until death ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01280565 on ClinicalTrials.gov Archive Site
Overall Survival (OS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until death ] [ Designated as safety issue: No ]
Overall Survival (OS) [ Time Frame: until death ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Melanoma
  • Drug: masitinib
    masitinib 7.5 mg/kg/day
  • Drug: Dacarbazine
    dacarbazine IV bolus at 1,000 mg/m2 once every three weeks
  • Experimental: masitinib
    Intervention: Drug: masitinib
  • Active Comparator: dacarbazine
    Intervention: Drug: Dacarbazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jean-Jacques GROB, MD, PhD +33 (0)4 91 74 47 14 jean-jacques.grob@mail.ap-hm.fr
France
 
NCT01280565
AB08026
Yes
AB Science
AB Science
Not Provided
Not Provided
AB Science
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP