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NCT00511459 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients

A Phase 2 study, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
228
Enrollment target

NCT00511459 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 228 participants.

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The verdict

NCT00511459, a Phase 2 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
228 participants
Enrollment target

Study Summary

This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Interventions

  • DRUG Bevacizumab
  • DRUG AMG 386
  • DRUG AMG 386 Placebo

Trial Details

FieldValue
Enrollment Target 228 participants
Start Date 2007-07
Est. Completion 2014-05
Phase Phase 2

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT00511459

The ClinicalTrials.gov registry entry for NCT00511459 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.

NCT00511459 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00511459 about?

NCT00511459 is a clinical study titled "Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients". This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast ...

What is the current status of trial NCT00511459?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 228 participants. The study started on 2007-07. Estimated completion is 2014-05.

What interventions are being tested in trial NCT00511459?

The interventions under investigation include: Bevacizumab (DRUG), AMG 386 (DRUG), AMG 386 Placebo (DRUG).

Who is sponsoring clinical trial NCT00511459?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

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

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.