Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

AB Science

Status and phase

Completed

Phase 3

Conditions

Gastrointestinal Stromal Tumors

Treatments

Drug: Sunitinib

Drug: Masitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01694277

AB11002

Details and patient eligibility

About

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.

Full 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).

Enrollment

258 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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