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

NCT00441467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-03-25

Study results available
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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

DRUG

Glufosfamide

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

Sponsors & Collaborators

  • Threshold Pharmaceuticals

    collaborator INDUSTRY

  • Eleison Pharmaceuticals LLC.

    lead INDUSTRY

Principal Investigators

  • Lee Cranmer, MD, PhD · University of Arizona

  • David Mendelson, MD · Premiere Oncology of Arizona

  • Douglas Adkins, MD · Washington University School of Medicine, Division of Oncology

  • Gina D'Amato, MD · H. Lee Moffitt Cancer Center

  • Gerald Rosen, MD · St. Vincent's Comprehensive Cancer Center

  • Claire Verschraegen, MD · University of New Mexico Cancer Center

  • Kristen Ganjoo, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441467 on ClinicalTrials.gov