Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01280565 |
|
Recruitment Status :
Terminated
(Sponsor decision based on portfolio prioritization)
First Posted : January 21, 2011
Last Update Posted : November 5, 2020
|
Sponsor:
AB Science
Information provided by (Responsible Party):
AB Science
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Melanoma | Drug: Masitinib Drug: Dacarbazine | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 134 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 2011 |
| Actual Primary Completion Date : | August 2019 |
| Actual Study Completion Date : | August 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
MedlinePlus related topics:
Melanoma
Drug Information available for:
Dacarbazine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Masitinib
Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
|
Drug: Masitinib
Masitinib 7.5 mg/kg/day
Other Name: AB1010 |
|
Active Comparator: Dacarbazine
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
|
Drug: Dacarbazine
IV bolus at 1,000 mg/m2 once every 3 weeks
Other Name: DTIC |
Primary Outcome Measures :
- Objective Response Rate [ Time Frame: 24 weeks ]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 [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]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) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]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.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
Locations
| United States, North Carolina | |
| Blumenthal Cancer Centre | |
| Charlotte, North Carolina, United States, 28204 | |
| Czechia | |
| University Hospital Hradec Králové | |
| Hradec Králové, Czechia, 500 12 | |
| France | |
| Hôpital Saint Andre | |
| Bordeaux, France, 33075 | |
| Centre Hospitalier LE MANS | |
| Le Mans, France, 72037 | |
| Hôpital Sainte Marguerite | |
| Marseille, France, 13274 | |
| Germany | |
| Klinik und Poliklinik für Hautkrankheiten | |
| Münster, Germany, 48149 | |
| Italy | |
| Istituto Europeo di Oncologia | |
| Milano, Italy, 20141 | |
| Russian Federation | |
| N.N.Blokhin Russian Cancer Research Centre | |
| Moscow, Russian Federation, 115478 | |
| Spain | |
| Hospital General de Valencia | |
| Valencia, Spain, 46014 | |
Sponsors and Collaborators
AB Science
Investigators
| Principal Investigator: | Jean-Jacques GROB, MD, PhD | Hôpital Sainte Marguerite, Marseille, France |
| Responsible Party: | AB Science |
| ClinicalTrials.gov Identifier: | NCT01280565 |
| Other Study ID Numbers: |
AB08026 |
| First Posted: | January 21, 2011 Key Record Dates |
| Last Update Posted: | November 5, 2020 |
| Last Verified: | December 2019 |
Keywords provided by AB Science:
|
Melanoma Tyrosine kinase inhibitor c-Kit juxta membrane mutation |
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 Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |