Clinical trial NCT00812240: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastro-Intestinal Stromal Tumor
GIST
metastatic
non resectable locally advanced
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Main inclusion criteria include:

* Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST
* 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

Main exclusion criteria include:

* Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria
* 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From day of randomization to disease progression or death, assessed for a maximum of 96 months]
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From day of randomization to death, assessed for a maximum of 96 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: MD Anderson Cancer Center
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Abbeville
country: France
facility: Centre Hospitalier d'Abbeville
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: Hôpital Morvan
city: Créteil
country: France
facility: Hôpitalo Henri Mondor
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dijon
country: France
facility: Hopital Bocage
city: Dreux
country: France
facility: Centre Hospitalier Victor Jousselin
city: Evreux
country: France
facility: Clinique Pasteur
city: Gap
country: France
facility: Centre Hospitalier de Gap
city: La Roche sur Yon
country: France
facility: CHD de Vendée
city: La Rochelle
country: France
facility: Centre Hsopitalier de La Rochelle
city: Libourne
country: France
facility: Centre Hospitalier Robert Boulin
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: Centre Val d'Aurèle
city: Nantes
country: France
facility: Centre René Gauducheau
city: Orléans
country: France
facility: Hôpital de la Source
city: Paris
country: France
facility: Groupe Hospitalier Diaconesse Croix Saint Simon
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Bichat Claude Bernard
city: Paris
country: France
facility: Hôpital Tenon
city: Reims
country: France
facility: Hôpital Robert Debré
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Saint-Cloud
country: France
facility: Centre René Huguenin
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
city: Beirut
country: Lebanon
facility: Hôpital Saint-Georges
city: Beirut
country: Lebanon
facility: Makassed General Hospital Tarik Jadide
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Jdeïdé
country: Lebanon
facility: Hôpital Saint-Joseph
Study officials:
affiliation: Centre Oscar Lambret, Lille, France
name: Antoine Adenis, MD
role: PRINCIPAL_INVESTIGATOR
References: