drugset / Trial / NCT00442598

Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

NCT00442598 ↗

Phase 2 Terminated 17 enrolled Eleison Pharmaceuticals LLC.
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objectives: * To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer * To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing Secondary objectives: * To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival * To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment Exploratory objective: * To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Timeline

Start
2007-01
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Glufosfamide Small molecule 1660 mg/m2 —
Subject Glufosfamide Small molecule 2500 mg/m2 —
Subject Glufosfamide Small molecule 5000 mg/m2 —

Indications