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.

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Contacts and Locations

Verified October 2015 by AB Science

Sponsor:

Information provided by (Responsible Party):

AB Science

ClinicalTrials.gov Identifier:

NCT01280565

First received: August 6, 2010

Last updated: October 7, 2015

Last verified: October 2015

History of Changes

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: 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:

MedlinePlus related topics: Melanoma

Drug Information available for: Dacarbazine

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

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


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

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

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
Study First Received:	August 6, 2010
Last Updated:	October 7, 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

ClinicalTrials.gov processed this record on August 16, 2017

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