Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Imatinib Mesylate

Criteria

Inclusion Criteria:

• Males and females, 18 or older

• CP or AD CML or Ph+ ALL

• Intolerant of resistant to imatinib

• ECOG PS 0-2 (CP CML)

• ECOG PS 0-3 (AD CML and Ph+ ALL)

• Adequate hepatic and renal function

Exclusion Criteria:

• Pregnant or breastfeeding females

• History of significant cardiac disease

• History of significant bleeding disorder (not CML)