NCT00442598

Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Eleison Pharmaceuticals LLC. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Glufosfamide

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-03-02
• Last updated: 2015-03-10
• Results posted: 2015-03-10

Locations

10 sites across 1 country: United States