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A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia

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Trial Information

A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of drug-related adverse events.

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Belgium: Institutional Review Board

Study ID:

CA180-083

NCT ID:

NCT00349518

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Chronic Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic and Advanced Phase CML and
  • Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

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