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NCT02088684 · ClinicalTrials.gov registry record · Phase 1
Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT02088684 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 70 participants.
The verdict
NCT02088684, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant. This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant; LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant. The Phase II portion of the study was planned to be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally advanced or metastatic breast cancer. Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer were planned to be enrolled.
Interventions
- DRUG fulvestrant
- DRUG LEE011
- DRUG BYL719
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2014-05-19 |
| Est. Completion | 2018-04-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02088684
The ClinicalTrials.gov registry entry for NCT02088684 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which fulvestrant is the first listed.
NCT02088684 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02088684 about?
NCT02088684 is a clinical study titled "Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer". The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant. This is a multi-center, op...
What is the current status of trial NCT02088684?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2014-05-19. Estimated completion is 2018-04-17.
What interventions are being tested in trial NCT02088684?
The interventions under investigation include: fulvestrant (DRUG), LEE011 (DRUG), BYL719 (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT02088684?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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