Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
Stopped early · Phase 1
Conditions studied: Advanced or Metastatic ER+ Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02734615
- Run by
- Novartis Pharmaceuticals
- People needed
- 199
- Starts
- 2016-06-14
- Expected to finish
- 2021-09-13
- Last updated by the study team
- 2022-08-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent must be obtained prior to any procedures
- Histologically and/or cytologically confirmed diagnosis of ER+/HER2- breast cancer
- Advanced or metastatic breast cancer
- Must be able to swallow tablets and capsules
You may not qualify if…
- Symptomatic CNS metastases
- Patients whose laboratory values do not meet protocol criteria
- Clinically significant cardiac disease
- Impaired gastrointestinal function (GI) or GI disease that may significantly alter the absorption of oral medications
- Other protocol defined inclusion/exclusion criteria may apply.
Where it is running
- Massachusetts General Hospital Massachusetts General Hospital — Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- MD Anderson Cancer Center SC - LSZ102X2101 — Houston, Texas, United States
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Lyon, France
- Novartis Investigative Site — Ulm, Germany
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Koto Ku, Tokyo, Japan
- Novartis Investigative Site — Singapore, Singapore
Full record on ClinicalTrials.gov
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