At a glance
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An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma
In Brief
A Phase 2 clinical trial evaluating Glufosfamide for Soft Tissue Sarcoma. Completed, enrolled 22 participants across 7 sites.
Detailed 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
Study Details
Timeline
Interventions
5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.