Phase I Safety and Efficacy Study of an Intravenous Formulation of the Anthracycline Analog, GPX-100, in the Treatment of Metastatic Breast Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of GPX-100 in outpatients with
incurable, solid tumors who are not candidates for effective systemic therapy. II. Evaluate
and quantify the toxicity of GPX-100 in this patient population. III. Identify any changes
in disease status in this patient population.
OUTLINE: This is an open label, multicenter, dose escalation study. Patients receive GPX-100
IV once every 3 weeks. Patients receive 2 courses of treatment in the absence of disease
progression or dose limiting toxicity. Treatment may continue for up to 6 courses (4 courses
with prior doxorubicin) in patients with responding or non-progressing disease. One patient
is entered at each of the first 3 dose levels. Cohorts of 3-6 patients are entered at
subsequent dose levels. The maximum tolerated dose of GPX-100 is defined as the dose at
which no more than 2 instances of dose limiting toxicity are observed in 6 patients.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Primary Purpose: Treatment
Frederick J. Dechow, PhD
United States: Federal Government
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|Mayo Clinic Jacksonville||Jacksonville, Florida 32224|