Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

• Status: Terminated
• Trial end date: 2021-09-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.