NCT00506142

Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma

A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. This may cause the cancer cells to die. Liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. The liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously. The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be studied. Approximately 50 patients will take part in this study.

Conditions

• Metastatic Malignant Uveal Melanoma

Interventions

Type	Name	Description
DRUG	Marqibo® (vincristine sulfate liposomes injection)	Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.

Timeline

• Start date: 2007-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2007-07-25
• Last updated: 2019-12-11
• Results posted: 2019-11-27

Locations

4 sites across 1 country: United States