A Study to Document the Long-Term Safety and Efficacy of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Previous Treatment and Have Completed the Previous Phase I/II Protocol (CA180-031/NCT00337454)
20 Years
75 Years
Both
Chronic Myelogenous Leukemia, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Trial Information
A Study to Document the Long-Term Safety and Efficacy of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Previous Treatment and Have Completed the Previous Phase I/II Protocol (CA180-031/NCT00337454)
Inclusion Criteria:
- Subjects who were eligible and completed the previous Phase I and II study
(CA180031/NCT00337454) and for whom the principal investigator has deemed that
continuation of study drug is in the best interest of the subject
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Subjects who are eligible and willing to undergo transplantation at pre-study
- Non-hematologic intolerance to Dasatinib (BMS-354825) in the previous Phase I and II
study (CA180031/NCT00337454)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation
Outcome Description:
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome Time Frame:
baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation
Safety Issue:
Yes
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CA180-036
NCT ID:
NCT01030718
Start Date:
January 2006
Completion Date:
June 2009
Related Keywords:
- Chronic Myelogenous Leukemia
- Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
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