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NCT01075100 · ClinicalTrials.gov registry record · Phase 2

Ixabepilone + Carboplatin Metastatic Breast Cancer

A Phase 2 study, sponsored by US Oncology Research.

Completed
Registry status
Phase 2
Development phase
103
Enrollment target

NCT01075100 is a Phase 2 study that has completed, run by US Oncology Research. The registered enrollment target is 103 participants.

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The verdict

NCT01075100, a Phase 2 study, has completed, sponsored by US Oncology Research.

COMPLETED
Registry status
Phase 2
Development phase
103 participants
Enrollment target

Study Summary

Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination with gemcitabine or paclitaxel has activity in metastatic breast cancer (MBC); there is also demonstrated activity of the gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this combination at the doses and schedule proposed for this Phase II trial (BMS data on file).

Interventions

  • DRUG Carboplatin
  • DRUG Ixabepilone

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2010-01
Est. Completion 2013-06
Phase Phase 2

Sponsor

US Oncology Research

27 total trials

What the Registry Record Tells You About NCT01075100

The ClinicalTrials.gov registry entry for NCT01075100 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Oncology Research, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.

NCT01075100 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01075100 about?

NCT01075100 is a clinical study titled "Ixabepilone + Carboplatin Metastatic Breast Cancer". Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination wi...

What is the current status of trial NCT01075100?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2010-01. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01075100?

The interventions under investigation include: Carboplatin (DRUG), Ixabepilone (DRUG).

Who is sponsoring clinical trial NCT01075100?

This trial is sponsored by US Oncology Research, which has 27 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.