drugset / Trial / NCT00442598
Safety and Efficacy Study of Glufosfamide in Ovarian Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glufosfamide | Small molecule | 1660 mg/m2 | — |
| Subject | Glufosfamide | Small molecule | 2500 mg/m2 | — |
| Subject | Glufosfamide | Small molecule | 5000 mg/m2 | — |