Spots Global Cancer Trial Database for Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
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Trial Identification
Brief Title: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Official Title: A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment
Study ID: NCT00812240
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Evreux, , 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
Contact Details
Name: Antoine Adenis, MD
Affiliation: Centre Oscar Lambret, Lille, France
Role: PRINCIPAL_INVESTIGATOR
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