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Study of GPX-100 in the Treatment of Metastatic Breast Cancer

NCT00123877 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2007-01-09

No results posted yet for this study

Summary

The purpose of this early Phase II multicenter trial is to determine the objective clinical response to GPX-100, an anthracycline similar to doxorubicin, in up to 40 patients with newly diagnosed metastatic breast cancer. GPX-100 is unique among anthracyclines because it is not converted to doxorubicinol during metabolism in the body. This metabolite has been shown to be a major cause of damage to the heart (cardiotoxicity) in laboratory studies. Eligible patients who are enrolled in this study will receive GPX-100 as a single agent at the beginning of as many as 8 three week long cycles of chemotherapy. Objective measurements of tumor response will be made by computed tomography (CT) scans.

Conditions

Interventions

DRUG

GPX-100 (13-deoxydoxorubicin)

Sponsors & Collaborators

  • Gem Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • John H. Ward, MD · Hunstman Cancer Institute, University of Utah School of Medicine, Salt Lake City, UT

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Completion
2005-11-30

Countries

  • United States
  • Bulgaria

Study Locations

More Related Trials

Entities

Diseases

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 NCT00123877 on ClinicalTrials.gov