Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00345826|
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : January 8, 2013
RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects of dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: dasatinib||Phase 1|
- Determine the long-term safety and tolerability of dasatinib in patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia resistant or intolerant to imatinib mesylate.
- Describe any hematologic or cytogenetic response in patients treated with this drug.
- Determine the duration of hematologic and cytogenetic response in patients using this drug during trial UCLA-0303035.
- Determine the progression-free survival and overall survival of patients treated with this drug.
OUTLINE: This is an open-label, roll-over study of protocol UCLA-0303035.
Patients receive oral dasatinib once or twice daily for 5, 6, or 7 days. Treatment repeats every 7 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||July 2010|
|Experimental: Dasatinib||Drug: dasatinib|
- Long term safety and tolerability [ Time Frame: 5 years ]
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): NCT00345826
|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|