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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 is a Phase 2 study that has completed, run by Celgene Corporation. The registered enrollment target is 100 participants.

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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

FieldValue
Enrollment Target 100 participants
Start Date 2001-06
Phase Phase 2

Sponsor

Celgene Corporation

40 total trials

What the Registry Record Tells You About NCT00046514

The ClinicalTrials.gov registry entry for NCT00046514 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 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.

NCT00046514 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.