CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Marqibo® (vincristine sulfate liposomes injection)drug
Likely dose
Marqibo® (vincristine sulfate liposomes injection) 2.25 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00506142
NCT00506142Phase 2Completed

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

Spectrum Pharmaceuticals, Inc·interventional·Posted Jul 25, 2007·Updated Dec 11, 2019

In Brief

A Phase 2 clinical trial evaluating Marqibo® (vincristine sulfate liposomes injection) for Metastatic Malignant Uveal Melanoma. Completed, enrolled 54 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2007
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 18.9 years ago

Interventions

Marqibo® (vincristine sulfate liposomes injection)drug

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.