GPX-100 in Treating Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00003403|
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : April 23, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of GPX-100 in treating patients who have solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: GPX-100||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Safety and Efficacy Study of an Intravenous Formulation of the Anthracycline Analog, GPX-100, in the Treatment of Metastatic Breast Cancer|
|Study Start Date :||August 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003403
|United States, Florida|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||Frederick J. Dechow, PhD||Gem Pharmaceuticals|