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Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
This study has been completed.
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00101647
  Purpose

The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.


Condition Intervention Phase
Chronic Myelogenous Leukemia
Drug: Dasatinib
Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Imatinib Imatinib mesylate Dasatinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Major and overall hematologic response rate in imatinib resistant patients [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of overall hematologic response [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Duration of major hematological response [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • time to major hematologic response [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • major cytogenetic response rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • major molecular response rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • quality of life measures [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • assessment of safety and tolerability of BMS-354825 [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • pharmacokinetics analysis of BMS-354825 & pharmacogenomics [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • time to overall hematologic response [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: December 2004
Study Completion Date: March 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Dasatinib
Tablets, Oral, 70 mg, twice daily, until disease porgression or untolerable toxicity, switch to the roll-over study or study closure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with Philadelphia chromosome positive PH+ (or BCR/ABL+) accelerated phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
  • Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not need to be their most recent CML treatment prior to coming on this study.
  • Men and women, 18 years of age or older.
  • Adequate hepatic function.
  • Adequate renal function.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • Subjects who are eligible and willing to undergo transplantation during the screening period.
  • A serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy.
  • Uncontrolled or significant cardiovascular disease.
  • Medications that increase bleeding risk.
  • Medications that change heart rhythms.
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
  • History of significant bleeding disorder unrelated to CML.
  • Concurrent incurable malignancy other than CML.
  • Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
  • Prior therapy with BMS-354825.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101647

  Show 70 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA180-005
Study First Received: January 12, 2005
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00101647  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Chronic myelogenous leukemia (CML): Accelerated phase

Study placed in the following topic categories:
Imatinib
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Leukemia, Myeloid, Accelerated Phase
Dasatinib
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009