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NCT01339442 · ClinicalTrials.gov registry record · Phase 1
BKM120 and Fulvestrant for Treating Postmenopausal Patients With Estrogen Receptor-Positive Stage IV Breast Cancer
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01339442: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT01339442 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01339442, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This phase I trial will determine the Maximum Tolerated Dose (MTD) of BKM120 when given together with fulvestrant in treating postmenopausal patients with estrogen receptor-positive (ER+) stage IV breast cancer. The toxicity profile of this combination therapy will also be described. Inhibition of PI3K by BKM120 may enhance programmed cell death (apoptosis) in estrogen receptor positive (ER+) breast cancer cells. Giving fulvestrant together with BKM 120 may enhance this apoptotic effect, providing a novel therapeutic strategy for patients with metastatic ER+ breast cancer.
Primary Outcome
Highest dose level at which no more than 1 of 6 patients develops a dose-limiting toxicity
Interventions
- DRUG Fulvestrant
- PROCEDURE biopsy
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-11-14 |
| Est. Completion | 2016-12-28 |
| Phase | Phase 1 |
What the finished NCT01339442 record still lists
NCT01339442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT01339442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01339442 about?
NCT01339442 is a clinical study titled "BKM120 and Fulvestrant for Treating Postmenopausal Patients With Estrogen Receptor-Positive Stage IV Breast Cancer". This phase I trial will determine the Maximum Tolerated Dose (MTD) of BKM120 when given together with fulvestrant in treating postmenopausal patients with estrogen receptor-positive (ER+) stage IV breast cancer. The toxicity profile of this combination therapy will also be described. Inhibition of P...
What is the current status of trial NCT01339442?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2011-11-14. Estimated completion is 2016-12-28.
What interventions are being tested in trial NCT01339442?
The interventions under investigation include: Fulvestrant (DRUG), biopsy (PROCEDURE), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01339442?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01339442's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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