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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 is a Phase 3 study that has completed, run by Celgene Corporation. The registered enrollment target is 460 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00046527
The ClinicalTrials.gov registry entry for NCT00046527 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene Corporation, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ABI-007 is the first listed.
NCT00046527 reports 0 study locations.
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.
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