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

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

ClinicalTrials.gov Identifier: NCT02734615

Novartis Reference Number: CLSZ102X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Advanced or Metastatic ER+ Breast Cancer
Phase 
Phase 1
Overall status 
Active, not recruiting
Enrollment count 
200 participants
Start date 
Jun 14, 2016
Completion date 
Oct 30, 2020
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LSZ102
LSZ102
Drug
LEE011
LEE011
Drug
BYL719
BYL719

Eligibility 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.

Study Locations

United States
Massachusetts General Hospital Massachusetts General Hospital
-
Boston, 02114
Massachusetts
United States
Memorial Sloan Kettering Cancer Center
-
New York, 10065
New York
United States
MD Anderson Cancer Center SC - LSZ102X2101
-
Houston, 77030
Texas
United States
Belgium
Novartis Investigative Site
-
Bruxelles, 1200
-
Belgium
France
Novartis Investigative Site
-
Lyon Cedex, 69373
-
France
Germany
Novartis Investigative Site
-
Ulm, 89081
-
Germany
Italy
Novartis Investigative Site
-
Milano, 20133
MI
Italy
Novartis Investigative Site
-
Milano, 20141
MI
Italy
Japan
Novartis Investigative Site
-
Koto ku, 135 8550
Tokyo
Japan
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore

Have a question?

Call 1-999-669-6682 or email [email protected]