drugset / Trial / NCT00145041

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

NCT00145041

Phase 1 Completed 7 enrolled Acrotech Biopharma Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-02
Primary completion
2007-09
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Vincristine Small molecule 1 mg/m2 Intravenous

Indications