TRIAL DETAIL

A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Imatinib in Patients With Gastro-Intestinal Stromal Tumour in First Line Medical Treatment

Drug:	Masitinib, (AB1010)
Trial Name:	A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Imatinib in Patients With Gastro-Intestinal Stromal Tumour in First Line Medical Treatment
NCT#:	NCT00812240
Conditions:	Gastrointestinal Stromal Tumor
Status:	Unknown
Phase:	3	Start Date 12/01/2008	Age of Trial (yrs) 15.4
Treatment Phase:	First-line
Drug Category:	KIT/PDGFRA inhibitor
Strategy:	Block KIT
Trial Type:	Specifically GIST and only GIST
Other Protocol IDs:	AB04030
Sponsor:	AB Science
Patient Contact:	Centre Oscar Lambret Antoine Adenis, M.D. a-adenis@o-lambret.fr +33 (0)3 20 29 59 59
Contact email:
Contact Phone:
Randomized:	Randomized
IV or Oral:	Oral
Trial Notes:	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 Tumour in First Line Medical Treatment

Trial Links

Ohio State trial description

WHO listing

Sylvester CCC Trial Listing

Trial Results

Drug Information

AB Science website

Comparative Toxicogenomics Database

Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial

Masitinib Phase II Trial Reports Benefit in New GISTs

Masitinib, (AB1010), a potent and selective TKI of targeting KIT (PDF)

Press Release - Masitinib extends overall survival in randomized phase II trial for GIST vs. Sutent for second line treatment

Oral tyrosine kinase inhibitor masitinib in combination with gemcitabine in patients with advanced pancreatic cancer: A multicenter phase II study.

AB Science reports phase 3 study results of masitinib in combination with Gemzar® for treatment of pancreatic cancer. Read more: AB Science reports phase 3 study results of masitinib in combination with Gemzar® for treatment of pancreatic cancer. - FiercePharma http://www.fiercepharma.com/press-releases/ab-science-reports-phase-3-study-results-masitinib-combination-gemzar-treat#ixzz2AsvsdSb7 Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma

AB Science announces a voluntary hold in the clinical studies of Masitinib worldwide (Jun, 2021).

Trial Sites

Name	Address	City	State	Zip	Country
MD Anderson - Orlando		Orlando	FL	32806	USA
Henry Ford Health System		Detroit	MI	48202	USA
Beth Israel Medical Center		New York	NY	10003	USA
Centre Oscar Lambret - Lille		Lille	Nord	59020	France
Centre Léon Bérard	28 rue Laennec	Lyon	Rhone	69373	France
Centre Georges Francois Leclerc		Dijon			France
Hopital Charles Nicolle		Rouen			France
Centre Hospitalier Victor Jousselin		Dreux			France
Centre Rene Huguenin		Saint-Cloud			France
Centre Rene Gauducheau		Nantes			France
Hôpital Jean Minjoz		Besancon	Doubs	25030	France
Institut Paoli Calmette		Marseilles	Bouches-du-Rhône	13273	France
Centre Val d'Aurele		Montpellier			France
Hopital de la Source		Orleans			France
Hopital Europeen Georges Pompidou		Paris	Ile de France	75908	France
Institut Bergonie	229 Cours Argonne	Bordeaux	Gironde	33076	France
Hopital Robert Debre		Reims	Marne	51092	France
Hopital Saint-Georges		Beirut			Lebanon
Hopital Saint-Joseph		Dora			Lebanon
Middle East Institute of Health		Bsalim			Lebanon
Hamoud Hospital		Saida			Lebanon
Emory Winship Cancer Institute	1365C Clifton Road	Atlanta	GA	30322	USA
Arthur G. James Cancer Hospital	300 W. 10th Ave.	Columbus	OH	43210	USA
Cancer Center of the Carolinas		Greenville	SC	29615	USA
Medical College of Wisconsin	8701 Watertown Plank Rd.	Milwaukee	WI	53226	USA
Centre Hospitalier d,Abbeville		Abbeville		80142	France
Institut Saints Catherine		Avignon		84000	France
Hopital Morvan		Brest		29200	France
Hopitalo Henri Mondor		Creteil		94000	France
Clinique Pasteur		Evreux		27000	France
Centre Hospitalier de Gap		Gap		05000	France
CHD de Vendee		La Roche sur Yon		85925	France
Centre Hospitalier de La Rochelle		La Rochelle		17000	France
Centre Hospitalier Robert Boulin		Libourne		33500	France
Hopital Bichat Claude Bernard		Paris		75018	France
Groups Hospitalier Diaconesse Croix Saint Simon		Paris		75012	France
Hopital Tenon		Paris		75020	France
Hotel Dieu de France		Beirut			Lebanon
Makassed General Hospital Tarik Jadide		Beirut			Lebanon
Rafik Hariri University Hospital		Beirut			Lebanon
Hopital Bocage		Dijon		21079	France
Clinique Armoricaine de Radiologie		Saint Brieuc		22000	France
Klinikum Wels-Grieskirchen, 4. med. Abteilung		Wels			Austria
Krankenhaus Wien-Hietzing, 5. med. Abteilung		Wien			Austria
Landeskrankenhaus Salzburg, Universitätsklinik für Innere Medizin I		Salzburg			Austria
Landeskrankenhaus Salzburg, Universitätsklinik für Innere Medizin III		Salzburg			Austria
LKH Feldkirch, Abteilung Interne E		Rankweil			Austria
Antwerp University Hospital Medical Oncology		Edegem			Belgium
Institut Jules Bordet		Brussels			Belgium
CHU d'Angers		Angers			France
Hôpital Avicenne		Bobigny			France
CHU de la Côte de Nacre		Caen			France
Service de Chirurgie Digestive Unité d'Oncologie Digestive CHU Estaing		Clermont Ferrand			France
Institut Daniel Hollard, 8-12 rue du Dr Calmette 38028 Grenoble		Grenoble			France
Centre Hospitalier Général de Mont de Marsan		Mont de Marsan			France
CHU De Nice Hôpital l'Archet II		Nice			France
Groupe Hospitalier Universitaire CAREMEAU		Nimes			France
Center GH Diaconesses-Croix Saint Simon		Paris			France
Groupe Hospitalier Universitaire Est Hôpital TENON		Paris			France
Hôpital HEGP		Paris			France
Hopital Paul Brousse		Paris			France
Hopital Saint-Joseph Service Oncologie		Paris			France
Hôpital Saint-Louis		Paris			France
Hôpital St Antoine		Paris		75571	France
Centre Hospitalier de Pau		Pau			France
CHU de Reimes - Hôpital Pontchaillou		Reims	Marne	51000	France
Centre Etienne DOLET Pôle Hospitalier Mutualiste		Saint Nazaire			France
Institut de Cancérologie de la Loire		Saint Priest en Jarez			France
HOPITAL CIVIL de Strasbourg		Strasbourg			France
Universitätsklinikum Köln (AöR) Kerpener Straße 62		50937 Koln			GERMANY
I. Medizinische Klinik und Poliklinik der Johannes-Gutenberg-Universität		55131 Mainz			GERMANY
Klinikum rechts der Isar der Technischen Universität München Verwaltung Fakultät Ismaninger Strasse 22		81 675 Munchen			GERMANY
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Onkoradiológia Osztály		Nyiregyháza			Hungary
Pécsi Tudományegyetem, Orvostudományi és észségtudományi Centrum, Onkoterápiás Intéze		Pécs			Hungary
Szegedi Tudományegyetem, Szent-Györgyi Albert Orvos- és Gyógyszerésztudományi Centrum, Onkoterápiás Klinika		Szeged			Hungary
Zala Megyei Kórház, Onkológia Osztály		Zalaegerszeg			Hungary
Hammoud Hospital University Medical Centre		Beirut			Lebanon
Saint Joseph Hospital–Raymond and Aïda Najjar Medical Center		Metn			Lebanon
Hospital Parc Tauli					Spain
Hospital Universitario de Canarias		Tenerife		38320	Spain
Hospital del Mar		Barcelona			Spain
Hospital San Pau		Barcelona		08041	Spain
Hospital Universitari Vall d'Hebrón		Barcelona		08035	Spain
Hospital 12 octobre		Madrid			Spain
Hospital Ramon y Cajal		Madrid			Spain
Hospital Universitario Clínico San Carlos		Madrid			Spain
Hospital Universitario Puerta de Hierro de Majadahonda		Madrid			Spain
Clinica universitaria Navarra		Plamplona			Spain
Hospital General Universitario de Valencia		Valencia			Spain
Rajavithi Hospital		Bangkok			Thailand
The Christie NHS Foundation Trust		Manchester		M20 4BX	UK
Centre Paul Strauss		Strasbourg		67065	France
Baptist Cancer Institute	800 Prudential Dr	Jacksonville	FL	32207	USA
Southeastern Medical Oncology Center	203 Cox Boulevard	Goldsboro	NC	27534	USA
St. Luke’s Cancer Center	801 Ostrum Street	Bethlehem	PA	18015	USA
University of Florida - College of Medicine - Hematology/Oncology	1600 SW Archer Road	Gainesville	FL	32610-0277	USA
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute		Los Angeles	CA		USA
Sinai Hospital of Baltimore		Baltimore	MD		USA
University of Pittsburgh Cancer Institute		Pittsburgh	PA	15232	USA
Dayton Clinical Oncology		Dayton	OH		USA
University of Miami, Sylvester Comprehensive Cancer Center	1475 Northwest 12th Ave	Miami	FL	33136	USA