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NCT01919229 · ClinicalTrials.gov registry record · Phase 2
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT01919229 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 14 participants.
The verdict
NCT01919229, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
Interventions
- DRUG letrozole
- DRUG LEE011 (ribociclib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01919229
The ClinicalTrials.gov registry entry for NCT01919229 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 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 2 interventions - of which letrozole is the first listed.
NCT01919229 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01919229 about?
NCT01919229 is a clinical study titled "A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)". This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
What is the current status of trial NCT01919229?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2013-10. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01919229?
The interventions under investigation include: letrozole (DRUG), LEE011 (ribociclib) (DRUG).
Who is sponsoring clinical trial NCT01919229?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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