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NCT00046527 · ClinicalTrials.gov registry record · Phase 3
Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer
A Phase 3 study, sponsored by Celgene Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
NCT00046527: Completed Phase 3 study, sponsored by Celgene Corporation.
NCT00046527 is a Phase 3 study that has completed, run by Celgene Corporation. The registered enrollment target is 460 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00046527, a Phase 3 study, has completed, sponsored by Celgene Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
Study Summary
Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required. This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer. This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication.
Interventions
- DRUG ABI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2001-06 |
| Phase | Phase 3 |
What the finished NCT00046527 record still lists
NCT00046527 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which ABI-007 is the first listed.
NCT00046527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00046527 about?
NCT00046527 is a clinical study titled "Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer". Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration...
What is the current status of trial NCT00046527?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2001-06.
What interventions are being tested in trial NCT00046527?
The interventions under investigation include: ABI-007 (DRUG).
Who is sponsoring clinical trial NCT00046527?
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 NCT00046527's enrollment target sits among peer trials
460 823rd of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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