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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Hays Medical Center
Hays, Kansas, United States
Hutchinson Regional Medical Center
Hutchinson, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Olathe Cancer Center
Olathe, Kansas, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Start Date
October 1, 2008
Primary Completion Date
August 1, 2014
Completion Date
August 1, 2014
Last Updated
July 2, 2015
80
ACTUAL participants
Dasatinib
DRUG
Pharmacological Study
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT02997761
NCT02234986
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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