Back to resultsMasitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit
Primary Purpose
Metastatic Melanoma
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Dacarbazine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Melanoma focused on measuring Melanoma, Tyrosine kinase inhibitor, c-Kit juxta membrane mutation
Eligibility 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
Sites / Locations
- Blumenthal Cancer Centre
- University Hospital Hradec Králové
- Hôpital Saint Andre
- Centre Hospitalier LE MANS
- Hôpital Sainte Marguerite
- Klinik und Poliklinik für Hautkrankheiten
- Istituto Europeo di Oncologia
- N.N.Blokhin Russian Cancer Research Centre
- Hospital General de Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Masitinib
Dacarbazine
Arm Description
Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
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
Outcomes
Primary Outcome Measures
Objective Response Rate
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
PFS
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.
Overall Survival (OS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01280565
Brief Title
Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit
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 Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
January 2011 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Melanoma, Tyrosine kinase inhibitor, c-Kit juxta membrane mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib
Arm Type
Experimental
Arm Description
Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
Arm Title
Dacarbazine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Description
Masitinib 7.5 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Other Intervention Name(s)
DTIC
Intervention Description
IV bolus at 1,000 mg/m2 once every 3 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
PFS
Description
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.
Time Frame
From day of randomization to disease progression or death, assessed for a maximum of 60 months
Title
Overall Survival (OS)
Description
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.
Time Frame
From day of randomization to death, assessed for a maximum of 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques GROB, MD, PhD
Organizational Affiliation
Hôpital Sainte Marguerite, Marseille, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blumenthal Cancer Centre
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University Hospital Hradec Králové
City
Hradec Králové
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Hôpital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Hospitalier LE MANS
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Hôpital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Klinik und Poliklinik für Hautkrankheiten
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
N.N.Blokhin Russian Cancer Research Centre
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Hospital General de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit
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