Study Stopped
Sponsor decision based on portfolio prioritization
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
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
1 other identifier
interventional
335
3 countries
41
Brief Summary
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2009
Longer than P75 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFebruary 1, 2023
December 1, 2019
9.5 years
December 19, 2008
January 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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).
From day of randomization to disease progression or death, assessed for a maximum of 96 months]
Secondary Outcomes (1)
Overall Survival (OS)
From day of randomization to death, assessed for a maximum of 96 months
Study Arms (4)
Masitinib (7.5)
EXPERIMENTALParticipants receive masitinib (7.5 mg/kg/day), given orally twice daily.
Masitinib (6.0)
EXPERIMENTALParticipants receive masitinib (6.0 mg/kg/day), given orally twice daily
Active Comparator (7.5)
ACTIVE COMPARATORParticipants receive imatinib at 400 or 600 mg per day
Active Comparator (6.0)
ACTIVE COMPARATORParticipants receive imatinib at 400 or 600 mg per day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AB Sciencelead
Study Sites (41)
MD Anderson Cancer Center
Orlando, Florida, 32806, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Ohio State University
Columbus, Ohio, 43210, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 290605, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Centre Hospitalier d'Abbeville
Abbeville, 80142, France
Institut Sainte Catherine
Avignon, 84000, France
Hôpital Jean Minjoz
Besançon, 25000, France
Institut Bergonié
Bordeaux, 33000, France
Hôpital Morvan
Brest, 29200, France
Hôpitalo Henri Mondor
Créteil, 94000, France
Centre Georges François Leclerc
Dijon, 21000, France
Hopital Bocage
Dijon, 21079, France
Centre Hospitalier Victor Jousselin
Dreux, 28100, France
Clinique Pasteur
Évreux, 27000, France
Centre Hospitalier de Gap
Gap, 05000, France
CHD de Vendée
La Roche-sur-Yon, 85925, France
Centre Hsopitalier de La Rochelle
La Rochelle, 17000, France
Centre Hospitalier Robert Boulin
Libourne, 33500, France
Centre Oscar Lambret
Lille, 59000, France
Centre Léon Bérard
Lyon, 69000, France
Institut Paoli Calmette
Marseille, 13200, France
Centre Val d'Aurèle
Montpellier, 34000, France
Centre René Gauducheau
Nantes, 44800, France
Hôpital de la Source
Orléans, 45000, France
Groupe Hospitalier Diaconesse Croix Saint Simon
Paris, 75012, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Hôpital Bichat Claude Bernard
Paris, 75018, France
Hôpital Tenon
Paris, 75020, France
Hôpital Robert Debré
Reims, 51000, France
Hôpital Charles Nicolle
Rouen, 76000, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22000, France
Centre René Huguenin
Saint-Cloud, 92210, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoine Adenis, MD
Centre Oscar Lambret, Lille, France
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 22, 2008
Study Start
January 1, 2009
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
February 1, 2023
Record last verified: 2019-12