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
This study is currently recruiting participants.
Verified October 2015 by AB Science
Sponsor:
AB Science
ClinicalTrials.gov Identifier:
NCT01280565
First Posted: January 21, 2011
Last Update Posted: October 8, 2015
Information provided by (Responsible Party):
AB Science
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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 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 |
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 ]
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: at week 6, 12, 18, 24 and every 12 weeks until death ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | December 2017 (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
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 Submitted: | August 6, 2010 |
| First Posted: | January 21, 2011 |
| 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 |