NCT00441467

Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Eleison Pharmaceuticals LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: 1\. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate Secondary Objectives: 1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival 2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma Exploratory Objectives: 1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET 2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Glufosfamide	5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-03-01
• Last updated: 2015-03-25
• Results posted: 2015-03-02

Locations

7 sites across 1 country: United States