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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 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 31 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01339442
The ClinicalTrials.gov registry entry for NCT01339442 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT01339442 reports 0 study locations.
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.
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