Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

• Status: Terminated
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

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

Details

• Lead Sponsor: AB Science
• Treatments: Imatinib Mesylate

Criteria

Main inclusion criteria include:

• Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST

• Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation

• c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative

Main exclusion criteria include:

• Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria

• 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