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NCT02154776 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
A Phase 1 study of Advanced or Metastatic Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 6
- Study locations
NCT02154776: Completed Phase 1 study of Advanced or Metastatic Breast Cancer, sponsored by Novartis Pharmaceuticals.
NCT02154776 is a Phase 1 study of Advanced or Metastatic Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 13 participants, below the 420-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02154776, a Phase 1 study of Advanced or Metastatic Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a multi-center, open-label, non-randomized, phase I study
Primary Outcome
Dose Escalation Phase: Frequency of DLTs at each dose level associated with administration of LEE011, buparlisib, and letrozole in a 28 day cycle
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG LEE011
- DRUG Buparlisib
Study Locations (6)
California
- University of California at Los Angeles UCLA SC - Los Angeles
Indiana
- Horizon Oncology Center SC - Lafayette
South Carolina
- Medical University of South Carolina SC - Charleston
Texas
- South Texas Accelerated Research Therapeutics SC - San Antonio
Utah
- University of Utah / Huntsman Cancer Institute SC-3 - Salt Lake City
Other
- Novartis Investigative Site - Madrid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-06-27 |
| Est. Completion | 2016-10-26 |
| Phase | Phase 1 |
What the finished NCT02154776 record still lists
NCT02154776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 420-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Letrozole is the first listed.
NCT02154776 lists 6 locations in 6 states (California, Indiana, South Carolina).
Frequently Asked Questions
What is clinical trial NCT02154776 about?
NCT02154776 is a clinical study titled "Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.". This is a multi-center, open-label, non-randomized, phase I study
What is the current status of trial NCT02154776?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2014-06-27. Estimated completion is 2016-10-26.
What conditions does trial NCT02154776 study?
This clinical trial studies the following conditions: Advanced or Metastatic Breast Cancer.
What interventions are being tested in trial NCT02154776?
The interventions under investigation include: Letrozole (DRUG), LEE011 (DRUG), Buparlisib (DRUG).
Who is sponsoring clinical trial NCT02154776?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02154776 being conducted?
This trial has 6 study locations across California, Indiana, South Carolina, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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