drugset / Trial / NCT00123877
Study of GPX-100 in the Treatment of Metastatic Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-03
- Primary completion
- —
- Completion
- 2005-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 13-deoxydoxorubicin | Small molecule | 105 mg/m2 | Intravenous |
| Subject | 13-deoxydoxorubicin | Small molecule | 140 mg/m2 | Intravenous |
| Subject | 13-deoxydoxorubicin | Small molecule | 170 mg/m2 | Intravenous |