Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Launched by AB SCIENCE · Sep 25, 2012

Keywords

ClinConnect Summary

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).

Gender

ALL

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