BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
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|ClinicalTrials.gov Identifier: NCT00064233|
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : August 3, 2020
RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: dasatinib||Phase 1|
- Determine the maximum tolerated dose, maximum administered dose, dose-limiting toxicity, and a recommended phase II dose of BMS-354825 in patients with chronic phase chronic myelogenous leukemia who have hematologic resistance to imatinib mesylate.
- Determine the safety and tolerability of this drug in these patients.
- Determine the plasma pharmacokinetics of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug, in terms of hematologic, cytogenetic, and molecular responses in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral BMS-354825 once daily on days 1-5. Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients may receive further treatment in the absence of disease progression.
Cohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, 20 additional patients receive treatment as in phase I at the MTD of BMS-354825.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: Approximately 50 patients (30 for phase I and 20 for phase II) will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-Escalation Study To Determine The Safety, Pharmacokinetics, And Pharmacodynamics Of BMS-354825 In The Treatment Of Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Hematologic Resistance To Imatinib Mesylate (Gleevec|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064233
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Charles Sawyers, MD||Jonsson Comprehensive Cancer Center|