Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title: An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer

Status Terminated

Clinical Trial 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

Clinical Trial Description

Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen.

In the weekly dosing schedule, treatment with glufosfamide 2,500 mg/m2 will be initiated only after the 1,660 mg/m2 treatment cohort has been enrolled and there is evidence that the dose of 1,660 mg/m2 has been well tolerated (See below Section on Pharmacokinetic/Statistical Analyses). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT00442598
• Study type: Interventional
• Source: Eleison Pharmaceuticals LLC.
• Status: Terminated
• Phase: Phase 2
• Start date: January 2007
• Completion date: April 2008