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Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction

Malignant Melanoma Clinical Trial

Official title:
An Evaluation of the Pharmacokinetic Profile of VSLI (Vincristine Sulfate Liposome Injection, 0.16 mg/mL) in Patients With Malignant Melanoma and Hepatic Dysfunction Secondary to Metastases

Clinical Trial Summary

The purpose of this study is to see how vincristine, when placed in an oil droplet called a liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body (pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in liver impairment, and who have relapsed after previous therapies.

Clinical Trial Description

OBJECTIVES:

Primary: To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases.

Secondary: To assess the safety and antitumor activity of VSLI in this population. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00145041
Study type Interventional
Source Acrotech Biopharma LLC
Contact
Status Completed
Phase Phase 1
Start date February 2005
Completion date November 2007
View Details
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