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

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

Timeline

Start

2007-03

Primary completion

2008-10

Completion

2008-10

Drugs

Indications