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NCT00123877 · ClinicalTrials.gov registry record · Phase 2
Study of GPX-100 in the Treatment of Metastatic Breast Cancer
A Phase 2 study, sponsored by Gem Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00123877 is a Phase 2 study that was terminated before completion, run by Gem Pharmaceuticals. The registered enrollment target is 40 participants.
The verdict
NCT00123877, a Phase 2 study, was terminated before completion, sponsored by Gem Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
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.
Interventions
- DRUG GPX-100 (13-deoxydoxorubicin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-03 |
| Est. Completion | 2005-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00123877
The ClinicalTrials.gov registry entry for NCT00123877 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gem Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GPX-100 (13-deoxydoxorubicin) is the first listed.
NCT00123877 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00123877 about?
NCT00123877 is a clinical study titled "Study of GPX-100 in the Treatment of Metastatic Breast Cancer". 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 doxorubi...
What is the current status of trial NCT00123877?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2005-03. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00123877?
The interventions under investigation include: GPX-100 (13-deoxydoxorubicin) (DRUG).
Who is sponsoring clinical trial NCT00123877?
This trial is sponsored by Gem Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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