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NCT02734615 · ClinicalTrials.gov registry record · Phase 1
Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 199
- Enrollment target
NCT02734615: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02734615 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 199 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (232% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02734615, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 199 participants
- Enrollment target
Study Summary
To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.
Primary Outcome
The dose escalation part of the study will be guided by well-established statistical methods/models to estimate the maximum tolerated doses (MTD)and/or recommended doses for expansion (RDE). Safety, pharmacokinetic and pharmacodynamics data will guide dose escalation decisions.
Interventions
- DRUG LEE011
- DRUG BYL719
- DRUG LSZ102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2016-06-14 |
| Est. Completion | 2021-09-13 |
| Phase | Phase 1 |
Why NCT02734615 stopped before completion
NCT02734615 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (232% higher).
The record links to 0 conditions, and to 3 interventions - of which LEE011 is the first listed.
NCT02734615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02734615 about?
NCT02734615 is a clinical study titled "Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers". To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metasta...
What is the current status of trial NCT02734615?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 199 participants. The study started on 2016-06-14. Estimated completion is 2021-09-13.
What interventions are being tested in trial NCT02734615?
The interventions under investigation include: LEE011 (DRUG), BYL719 (DRUG), LSZ102 (DRUG).
Who is sponsoring clinical trial NCT02734615?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02734615's enrollment target sits among peer trials
199 277th of 2000 higher than 1,724 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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