Status:
COMPLETED
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and e...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Signed written informed consent
- Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
- Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
- Men and women, ages 18 and older
- Key Exclusion Criteria
- A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
- Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00982488
Start Date
October 1 2007
End Date
December 1 2014
Last Update
January 22 2016
Active Locations (72)
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1
Pacific Cancer Medical Center Inc
Anaheim, California, United States, 92801
2
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
3
Ucla Department Of Medicine
Los Angeles, California, United States, 90095
4
Stanford University School Of Medicine
Stanford, California, United States, 94305