Clinical Trials Directory

Trials / Completed

CompletedNCT00608361

Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery

Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
80 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGDasatinibGiven PO
OTHERPharmacological StudyCorrelative studies

Timeline

Start date
2008-10-01
Primary completion
2014-08-01
Completion
2014-08-01
First posted
2008-02-06
Last updated
2015-07-02

Locations

23 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00608361. Inclusion in this directory is not an endorsement.

Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery (NCT00608361) · Clinical Trials Directory