Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Treatment
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Completed
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18 and over
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Pharmaceutical / Industry
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CA180-005 NCT00101647
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Trial Description
Summary 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. Eligibility 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.
- 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.
Trial Contact Information
Trial Lead Organizations/Sponsors Bristol-Myers Squibb Company - New York Bristol-Myers Squibb | ![](https://webarchive.library.unt.edu/eot2008/20081016234013im_/http://www.cancer.gov/images/spacer.gif) | Study Director |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00101647 Information obtained from ClinicalTrials.gov on October 10, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |