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

Soft Tissue Sarcoma Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00441467
Study type Interventional
Source Eleison Pharmaceuticals LLC.
Contact
Status Completed
Phase Phase 2
Start date March 2007
Completion date October 2008
View Details
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