Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2019 |
| Start Date: | June 14, 2016 |
| End Date: | October 30, 2020 |
| Contact: | Novartis Pharmaceuticals |
| Email: | Novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
We found this trial at
5
sites
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Boston, Massachusetts 02114
Principal Investigator: Dejan Juric, MD
Phone: 617-726-6500
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230 Park Avenue, 21st Floor
New York, New York 10169
New York, New York 10169
1-888-669-6682)
Principal Investigator: Komal Jhaveri
Phone: 646-422-4394
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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