Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science
• Treatments: Imatinib Mesylate; Sunitinib

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