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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349518

CA180-083

EUDRACTnr: 2006-001279-39

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)