Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Phase 3

Completed

Brief Summary: The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

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. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Masitinib	Masitinib	Participants receive masitinib (12 mg/kg/day), given orally twice daily.
Sunitinib	Sunitinib	Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From day of randomization to death, assessed for a maximum of 60 months	Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.

Secondary Outcome Measures

Name	Time	Method
Survival rate	Every 12 weeks until study completion, assessed for a maximum of 60 months	Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.
Progression Free Survival (PFS)	From day of randomization to disease progression or death, assessed for a maximum of 60 months	Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria and/or CHOI criteria.

Locations (5): Institut Bergonié
🇫🇷
Bordeaux, France
Hôpital l'Archet 2- Service de Cancérologie Digestive
🇫🇷
Nice, France
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Erasmus University Medical Center
🇳🇱
Rotterdam, Netherlands
Istituto per la Ricerca e la Cura del Cancro (IRCC)
🇮🇹
Candiolo, Italy