Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
