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Trial record 1 of 1 for:    AB08026
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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01280565
Recruitment Status : Unknown
Verified October 2015 by AB Science.
Recruitment status was:  Recruiting
First Posted : January 21, 2011
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Metastatic Melanoma Drug: masitinib Drug: Dacarbazine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Overall Progression Free Survival (PFS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until progression or death ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until death ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01280565     History of Changes
Other Study ID Numbers: AB08026
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

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