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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: Clinical Trial Phase 2 study, sponsored by Gem Pharmaceuticals.
NCT00123877 is a Phase 2 study that was terminated before completion, run by Gem Pharmaceuticals. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00123877 stopped before completion
NCT00123877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which GPX-100 (13-deoxydoxorubicin) is the first listed.
NCT00123877 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00123877's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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