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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01280565
Other study ID # AB08026
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 2011
Est. completion date August 2019

Study information

Verified date December 2019
Source AB Science
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 134
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Masitinib
Masitinib 7.5 mg/kg/day
Dacarbazine
IV bolus at 1,000 mg/m2 once every 3 weeks

Locations

Country Name City State
Czechia University Hospital Hradec Králové Hradec Králové
France Hôpital Saint Andre Bordeaux
France Centre Hospitalier LE MANS Le Mans
France Hôpital Sainte Marguerite Marseille
Germany Klinik und Poliklinik für Hautkrankheiten Münster
Italy Istituto Europeo di Oncologia Milano
Russian Federation N.N.Blokhin Russian Cancer Research Centre Moscow
Spain Hospital General de Valencia Valencia
United States Blumenthal Cancer Centre Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
AB Science

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Italy,  Russian Federation,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 weeks
Secondary 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. From day of randomization to disease progression or death, assessed for a maximum of 60 months
Secondary 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. From day of randomization to death, assessed for a maximum of 60 months
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