Phase I / Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
Trial Status: Closed to Accrual
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
California
San Francisco
UCSF Medical Center-Mount Zion
Status: COMPLETED
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email:
cancertrials@ucsf.edu
Maryland
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Dejan Juric
Phone: 877-726-5130
Email:
djuric@partners.org
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Dejan Juric
Phone: 617-761-5392
Email:
djuric@partners.org
New York
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
North Carolina
Durham
Duke University Medical Center
Status: ACTIVE
Texas
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Trial Phase Phase I
Trial Type Treatment
Lead Organization
Novartis Pharmaceuticals Corporation
- Primary ID CLSZ102X2101
- Secondary IDs NCI-2016-00957, 2015-004016-38
- Clinicaltrials.gov ID NCT02734615