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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: Completed Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT01248494 is a Phase 1 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The maximum tolerated dose for each of the arms will be defined as the highest dose tested in which a DLT is experienced by 0 out of 3 or 1 out of 6 patients among the dose levels. The first cohort of patients (3 patients) in each arm will be started at dose level 1, and each patient will be observed for 4 weeks on the specified dose.
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 |
What the finished NCT01248494 record still lists
NCT01248494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 4 interventions - of which Letrozole is the first listed.
NCT01248494 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01248494's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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