drugset / Trial / NCT00512460

RTA 744 Injection in Patients With Leptomeningeal Disease

NCT00512460

NaSingle-groupOpen-labelTreatment

Summary

1. The primary objectives of this study are: 1. To determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease (LMD) secondary to any type of primary tumor. 2. In a selected group of 6-10 patients who will receive RTA 744 at or near the maximum tolerated dose (MTD), to characterize the multiple-dose pharmacokinetics of RTA 744 in plasma and CSF. 2. The secondary objectives of this study are: 1. To document any potential antitumor activity of RTA 744 in this patient population. 2. To correlate pharmacokinetic information with clinical (efficacy and safety) responses, as a possible help in selecting appropriate doses for later studies.

Timeline

Start
2006-09
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Berubicin Small molecule 4.8 mg/m2 Intravenous