Clinical trial NCT01694277: Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
Official title: A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastrointestinal Stromal Tumour
GIST
non-resectable
metastatic
second line treatment
resistance to imatinib
tyrosine kinase inhibitor
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 258
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: 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).

Eligibility criteria: Main inclusion criteria include:

* Patient with histological proven metastatic GIST or non-operable locally advanced GIST
* Patient with c-Kit (CD117) positive tumor detected immuno-histochemically
* Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment.

Main exclusion criteria include:

* 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
* Pregnant, or nursing female patient

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From day of randomization to death, assessed for a maximum of 60 months
Secondary outcomes:
measure: Survival rate
timeFrame: Every 12 weeks until study completion, assessed for a maximum of 60 months
measure: Progression Free Survival (PFS)
timeFrame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Bordeaux
country: France
facility: Institut Bergonié
city: Nice
country: France
facility: Hôpital l'Archet 2- Service de Cancérologie Digestive
city: Candiolo
country: Italy
facility: Istituto per la Ricerca e la Cura del Cancro (IRCC)
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Institute Gustave Roussy
name: Axel Le Cesne, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: