Clinical Trials Directory

Trials / Completed

CompletedNCT00025415

Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction

A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction

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

Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with advanced malignancies and varying degrees of liver dysfunction. II. Determine the effects of hepatic dysfunction on the pharmacodynamics and pharmacokinetics of this drug in these patients. III. Determine the non-dose-limiting toxic effects of this drug in these patients. IV. Determine the response rate of these patients treated with this drug. V. Correlate the Childs-Pugh classification of hepatic dysfunction with observed toxic effects, pharmacodynamics, and pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver dysfunction (normal vs mild vs moderate vs severe). Patients receive oral imatinib mesylate daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients within each stratum (except normal stratum) receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.

Conditions

Interventions

TypeNameDescription
DRUGimatinib mesylateGiven orally
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2001-08-01
Primary completion
2005-01-01
First posted
2003-01-27
Last updated
2013-02-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00025415. Inclusion in this directory is not an endorsement.