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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2010-11 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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