NCT00145041

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Acrotech Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Vincristine Sulfate Liposomes Injection	Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-09-01
• Completion: 2007-11-01
• First posted: 2005-09-05
• Last updated: 2019-12-12
• Results posted: 2012-01-05

Locations

1 site across 1 country: United States