Overview

Korean Early Access Program

Status:
Approved for marketing
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This protocol allows CML and Ph+ ALL subjects who are resistant to or intolerant of imatinib mesylate, to potentially benefit from dasatinib. It is intended to provide patients with access to dasatinib while awaiting reimbursement decision in Korea and it will also provide additional data on the safety of dasatinib in Korean population
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Dasatinib
Criteria
Inclusion Criteria:

- Clinical diagnosis of CML or Ph+ ALL who have primary or acquired resistance to or
intolerance of imatinib mesylate

- ECOG performance status score 0 - 2

- Adequate hepatic, renal function