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NCT00046514 · ClinicalTrials.gov registry record · Phase 2
ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer
A Phase 2 study, sponsored by Celgene Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00046514: Completed Phase 2 study, sponsored by Celgene Corporation.
NCT00046514 is a Phase 2 study that has completed, run by Celgene Corporation. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00046514, a Phase 2 study, has completed, sponsored by Celgene Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against metastatic breast cancer. However, the Taxol formulation requires prolonged administration times, and there are safety problems that have been attributed to the solvent rather than the active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found to have fewer safety problems than Taxol, and may be administered safely at higher doses. This study will investigate the safety and efficacy of this new formulation of paclitaxel given intravenously once a week for three weeks, followed by a rest week. This cycle will be repeated until safety problems or treatment failure require that the patient stop therapy.
Interventions
- DRUG ABI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2001-06 |
| Phase | Phase 2 |
What the finished NCT00046514 record still lists
NCT00046514 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which ABI-007 is the first listed.
NCT00046514 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00046514 about?
NCT00046514 is a clinical study titled "ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer". The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against metastatic breast cancer. However, the Taxol formulation requires prolonged administration times, and there are safety problems that have been attributed to the solvent rather than the active ingredient, paclit...
What is the current status of trial NCT00046514?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2001-06.
What interventions are being tested in trial NCT00046514?
The interventions under investigation include: ABI-007 (DRUG).
Who is sponsoring clinical trial NCT00046514?
This trial is sponsored by Celgene Corporation, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00046514's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 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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