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NCT01248494 · ClinicalTrials.gov registry record · Phase 1

PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer

A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.

Completed
Registry status
Phase 1
Development phase
72
Enrollment target

NCT01248494 is a Phase 1 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 72 participants.

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The verdict

NCT01248494, a Phase 1 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
72 participants
Enrollment target

Study Summary

This is an open-label phase Ib multi-institution trial that evaluates the safety profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy combination in postmenopausal patients with hormone receptor-positive metastatic breast cancer.

Interventions

  • DRUG Letrozole
  • DRUG BEZ235
  • DRUG BKM120
  • DRUG BKM 120

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2010-11
Est. Completion 2016-05
Phase Phase 1

Sponsor

Vanderbilt-Ingram Cancer Center

189 total trials

What the Registry Record Tells You About NCT01248494

The ClinicalTrials.gov registry entry for NCT01248494 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.

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

NCT01248494 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01248494 about?

NCT01248494 is a clinical study titled "PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer". This is an open-label phase Ib multi-institution trial that evaluates the safety profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy combination in postmenopausal patients with...

What is the current status of trial NCT01248494?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2010-11. Estimated completion is 2016-05.

What interventions are being tested in trial NCT01248494?

The interventions under investigation include: Letrozole (DRUG), BEZ235 (DRUG), BKM120 (DRUG), BKM 120 (DRUG).

Who is sponsoring clinical trial NCT01248494?

This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 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.