Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction
This phase I trial studies the side effects and best dose of dasatinib in treating patients with solid tumors or lymphomas that are metastatic or cannot be removed by surgery. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) of dasatinib in patients with varying
degrees of hepatic impairment.
II. To estimate the pharmacokinetic (PK) profile of this drug in patients with varying
degrees of hepatic impairment.
III. To assess the safety profile and dose-limiting toxicities (if any) of dasatinib in
patients with varying degrees of hepatic impairment.
SECONDARY OBJECTIVES:
I. To describe any antitumor efficacy associated with dasatinib administration in patients
with varying degrees of hepatic impairment.
II. To examine whether the pharmacokinetic clearance of dasatinib correlates with hepatic
function as assessed by Child-Pugh Criteria, the National Cancer Institute (NCI) Organ
Dysfunction Working Group Criteria, or other assessments of liver function.
OUTLINE: This is a dose-escalation study.
Patients receive dasatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 28 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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