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

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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.


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
Houston, Texas 77030
Principal Investigator: Rachel M Layman
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Baltimore, Maryland 21287
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Boston, Massachusetts 02114
Principal Investigator: Dejan Juric, MD
Phone: 617-726-6500
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Bruxelles,
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230 Park Avenue, 21st Floor
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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