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
Recruitment status was Recruiting
Sponsor:
AB Science
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Metastatic Melanoma |
Drug: masitinib Drug: Dacarbazine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by AB Science:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280565
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | AB Science |
| ClinicalTrials.gov Identifier: | NCT01280565 History of Changes |
| Other Study ID Numbers: | AB08026 |
| Study First Received: | August 6, 2010 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas |
ClinicalTrials.gov processed this record on February 27, 2015