Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
NCT ID: NCT01506336
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2008-10-31
2012-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
masitinib
masitinib 12 mg/kg/day
masitinib
masitinib 12 mg/kg/day
sunitinib
sunitinib 50 mg/day
sunitinib
sunitinib 50 mg/day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
masitinib
masitinib 12 mg/kg/day
sunitinib
sunitinib 50 mg/day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
4. Patients resistant to imatinib at dose of 400 mg/day
Exclusion Criteria
2. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AB Science
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Axel Le Cesne, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Gustave Roussy, Villejuif, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute Gustave Roussy (IGR)
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Adenis A, Blay JY, Bui-Nguyen B, Bouche O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blesius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-1769. doi: 10.1093/annonc/mdu237. Epub 2014 Jul 25.
Related Links
Access external resources that provide additional context or updates about the study.
Publication of clinical study results
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AB07001
Identifier Type: -
Identifier Source: org_study_id