Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- Registration Number
- NCT00812240
- Lead Sponsor
- AB Science
- Brief Summary
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
- Detailed Description
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 335
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Comparator (7.5) Imatinib Participants receive imatinib at 400 or 600 mg per day Masitinib (7.5) Masitinib Participants receive masitinib (7.5 mg/kg/day), given orally twice daily. Masitinib (6.0) Masitinib Participants receive masitinib (6.0 mg/kg/day), given orally twice daily Active Comparator (6.0) Imatinib Participants receive imatinib at 400 or 600 mg per day
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) From day of randomization to disease progression or death, assessed for a maximum of 96 months] Progression Free Survival is defined as the time from randomization to first documentation of objective tumor progression (date of tumor assessment documenting progressive disease assessed by CT Scan according to RECIST 1.1 and based on central review) or to death due to any cause (whichever comes first).
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From day of randomization to death, assessed for a maximum of 96 months Overall survival is defined as time in months from the randomization date to the date of death due to any cause
Trial Locations
- Locations (41)
Centre Val d'Aurèle
🇫🇷Montpellier, France
Makassed General Hospital Tarik Jadide
🇱🇧Beirut, Lebanon
Hôpital Saint-Georges
🇱🇧Beirut, Lebanon
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hôpital de la Source
🇫🇷Orléans, France
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
CHD de Vendée
🇫🇷La Roche sur Yon, France
Institut Paoli Calmette
🇫🇷Marseille, France
Centre Hsopitalier de La Rochelle
🇫🇷La Rochelle, France
Beth Israel Medical Center
🇺🇸New York, New York, United States
Institut Sainte Catherine
🇫🇷Avignon, France
Centre René Gauducheau
🇫🇷Nantes, France
Centre Léon Bérard
🇫🇷Lyon, France
Hopital Bocage
🇫🇷Dijon, France
Centre Hospitalier Victor Jousselin
🇫🇷Dreux, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Hospitalier d'Abbeville
🇫🇷Abbeville, France
Hôpital Jean Minjoz
🇫🇷Besançon, France
Hôpitalo Henri Mondor
🇫🇷Créteil, France
Rafik Hariri University Hospital
🇱🇧Beirut, Lebanon
Groupe Hospitalier Diaconesse Croix Saint Simon
🇫🇷Paris, France
Hotel Dieu de France
🇱🇧Beirut, Lebanon
Institut Bergonié
🇫🇷Bordeaux, France
Hôpital Morvan
🇫🇷Brest, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Clinique Pasteur
🇫🇷Evreux, France
Centre Hospitalier de Gap
🇫🇷Gap, France
Clinique Armoricaine de Radiologie
🇫🇷Saint Brieuc, France
Hôpital Tenon
🇫🇷Paris, France
Centre René Huguenin
🇫🇷Saint-Cloud, France
Institut de Cancérologie de la Loire
🇫🇷Saint-Priest-en-Jarez, France
Hôpital Saint-Joseph
🇱🇧Jdeïdé, Lebanon
Centre Hospitalier Robert Boulin
🇫🇷Libourne, France
Hôpital Bichat Claude Bernard
🇫🇷Paris, France
Hôpital Charles Nicolle
🇫🇷Rouen, France
Hôpital Robert Debré
🇫🇷Reims, France
MD Anderson Cancer Center
🇺🇸Orlando, Florida, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States