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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

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 : Active, not recruiting
First Posted : January 21, 2011
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief 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.

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

Detailed Description:
Masitinib is a selective tyrosine kinase inhibitor with potent activity against the juxta membrane domain of c-Kit. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study was to evaluate the efficacy and safety of masitinib with respect to dacarbazine in the treatment of non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit. Following a protocol amendment, the dacarbarzine treatment group was closed and recruitment restricted to masitinib treatment of chemo-naïve (first-line) patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 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 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine

Arm Intervention/treatment
Experimental: Masitinib
Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
Drug: Masitinib
Masitinib 7.5 mg/kg/day
Other Name: AB1010

Active Comparator: Dacarbazine
Participants receive dacarbazine, given via IV bolus at 1,000 mg/m2 once every 3 weeks. Following a protocol amendment, the dacarbarzine treatment group has been closed
Drug: Dacarbazine
IV bolus at 1,000 mg/m2 once every 3 weeks
Other Name: DTIC




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 24 weeks ]
    Estimated as the number of patients with documented partial response or complete response defined according to the RECIST criteria, divided by the number of randomized patients


Secondary Outcome Measures :
  1. PFS [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]
    Progression Free Survival (PFS) is defined as the delay between the date of randomization to the date of documented progression (according to RECIST) or any cause of death during the study.

  2. Overall Survival (OS) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]
    Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main inclusion criteria include:

  • 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 (mutation in exon 9, 11 or 13) 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 not previously treated for melanoma (first-line)

Main exclusion criteria include:

  • Pregnant, or nursing female patient
  • Patient with active brain metastases.
  • Prior treatment with a tyrosine kinase c-Kit inhibitor

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


Locations
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United States, North Carolina
Blumenthal Cancer Centre
Charlotte, North Carolina, United States, 28204
Czechia
University Hospital Hradec Králové
Hradec Králové, Czechia, 500 12
France
Hôpital Saint Andre
Bordeaux, France, 33075
Centre Hospitalier LE MANS
Le Mans, France, 72037
Hôpital Sainte Marguerite
Marseille, France, 13274
Germany
Klinik und Poliklinik für Hautkrankheiten
Münster, Germany, 48149
Italy
Istituto Europeo di Oncologia
Milano, Italy, 20141
Russian Federation
N.N.Blokhin Russian Cancer Research Centre
Moscow, Russian Federation, 115478
Spain
Hospital General de Valencia
Valencia, Spain, 46014
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Jean-Jacques GROB, MD, PhD Hôpital Sainte Marguerite, Marseille, France

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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: February 7, 2019
Last Verified: February 2019

Keywords provided by AB Science:
Melanoma
Tyrosine kinase inhibitor
c-Kit juxta membrane mutation

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas