Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
NCT ID: NCT00812240
Last Updated: 2023-02-01
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.
TERMINATED
PHASE3
335 participants
INTERVENTIONAL
2009-01-31
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Masitinib in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of Recurrence
NCT02009423
Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST)
NCT01323400
A Study of Nilotinib Versus Imatinib in GIST Patients
NCT00785785
Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)
NCT01271712
Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy
NCT05132738
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.
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 (7.5)
Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
Masitinib
Masitinib (6.0)
Participants receive masitinib (6.0 mg/kg/day), given orally twice daily
Masitinib
Active Comparator (7.5)
Participants receive imatinib at 400 or 600 mg per day
Imatinib
imatinib 400 mg or 600 mg per day, per os
Active Comparator (6.0)
Participants receive imatinib at 400 or 600 mg per day
Imatinib
imatinib 400 mg or 600 mg per day, per os
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Masitinib
Imatinib
imatinib 400 mg or 600 mg per day, per os
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
* c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative
* Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
* 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.
Antoine Adenis, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret, Lille, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MD Anderson Cancer Center
Orlando, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
Henry Ford Health System
Detroit, Michigan, United States
Beth Israel Medical Center
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Centre Hospitalier d'Abbeville
Abbeville, , France
Institut Sainte Catherine
Avignon, , France
Hôpital Jean Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
Hôpital Morvan
Brest, , France
Hôpitalo Henri Mondor
Créteil, , France
Centre Georges François Leclerc
Dijon, , France
Hopital Bocage
Dijon, , France
Centre Hospitalier Victor Jousselin
Dreux, , France
Clinique Pasteur
Évreux, , France
Centre Hospitalier de Gap
Gap, , France
CHD de Vendée
La Roche-sur-Yon, , France
Centre Hsopitalier de La Rochelle
La Rochelle, , France
Centre Hospitalier Robert Boulin
Libourne, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmette
Marseille, , France
Centre Val d'Aurèle
Montpellier, , France
Centre René Gauducheau
Nantes, , France
Hôpital de la Source
Orléans, , France
Groupe Hospitalier Diaconesse Croix Saint Simon
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Bichat Claude Bernard
Paris, , France
Hôpital Tenon
Paris, , France
Hôpital Robert Debré
Reims, , France
Hôpital Charles Nicolle
Rouen, , France
Clinique Armoricaine de Radiologie
Saint-Brieuc, , France
Centre René Huguenin
Saint-Cloud, , France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, , France
Hotel Dieu de France
Beirut, , Lebanon
Hôpital Saint-Georges
Beirut, , Lebanon
Makassed General Hospital Tarik Jadide
Beirut, , Lebanon
Rafik Hariri University Hospital
Beirut, , Lebanon
Hôpital Saint-Joseph
Jdeïdé, , Lebanon
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AB04030
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.