Sorafenib for Imatinib/Sunitinib-failed GIST

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: Korean GIST Study Group
• Treatments: Imatinib Mesylate; Niacinamide; Sorafenib; Sunitinib

Criteria

Inclusion Criteria:

• age over 18 years

• advanced GIST

• failed (progressed and/or intolerable) after prior treatments for GIST

• ECOG performance status of 0~2

• resolution of all toxic effects of prior treatments

• no prior radiotherapy within 1 month before registration

• measurable lesion as defined by RECIST

• adequate marrow, hepatic, renal and cardiac functions

• provision of a signed written informed consent

Exclusion Criteria:

• severe co-morbid illness and/or active infections

• pregnant or lactating women

• history of other malignancies

• active CNS disease not controllable with radiotherapy or corticosteroids

• active and uncontrollable bleeding from gastrointestinal tract

• prior history of sorafenib use

• gastrointestinal obstruction or malabsorption syndrome