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NCT00140140 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer

A Phase 1 study, sponsored by Celgene.

Terminated
Registry status
Phase 1
Development phase
16
Enrollment target

NCT00140140 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 16 participants.

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The verdict

NCT00140140, a Phase 1 study, was terminated before completion, sponsored by Celgene.

TERMINATED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor support with G-CSF.

Interventions

  • DRUG Trastuzumab
  • DRUG vinorelbine
  • BIOLOGICAL G-CSF
  • DRUG ABI-007

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2005-08
Est. Completion 2008-02
Phase Phase 1

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT00140140

The ClinicalTrials.gov registry entry for NCT00140140 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.

NCT00140140 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00140140 about?

NCT00140140 is a clinical study titled "A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer". The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Hercepti...

What is the current status of trial NCT00140140?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2005-08. Estimated completion is 2008-02.

What interventions are being tested in trial NCT00140140?

The interventions under investigation include: Trastuzumab (DRUG), vinorelbine (DRUG), G-CSF (BIOLOGICAL), ABI-007 (DRUG).

Who is sponsoring clinical trial NCT00140140?

This trial is sponsored by Celgene, which has 308 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.