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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Advanced or Metastatic ER+ Breast Cancer

Treatments: Drug: LEE011; Drug: LSZ102; Drug: BYL719

Study type: Interventional

Funder types: Industry

Identifiers

NCT02734615

CLSZ102X2101

2015-004016-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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199 participants in 7 patient groups

Arm A

Experimental group

Description:

Patients will get LSZ102 single agent during dose escalation.

Treatment:

Drug: LSZ102

Arm B

Experimental group

Description:

Patients will get LSZ102 in combination with LEE011 during dose escalation.

Treatment:

Drug: LSZ102

Drug: LEE011

Arm C

Experimental group

Description:

Patients will get LSZ102 in combination with BYL719 during dose escalation.

Treatment:

Drug: BYL719

Drug: LSZ102

Arm 1

Experimental group

Description:

Patients will get LSZ102 single agent during dose expansion

Treatment:

Drug: LSZ102

Arm 2

Experimental group

Description:

Patients will get LSZ102 + LEE011 (LEE011 intermittent regimen) during dose expansion

Treatment:

Drug: LSZ102

Drug: LEE011

Arm 3

Experimental group

Description:

Patients will get LSZ102 + LEE011 (LEE011 continuous regimen) during dose expansion

Treatment:

Drug: LSZ102

Drug: LEE011

Arm 4

Experimental group

Description:

Patient will get LSZ102 in combination with BYL719 during dose expansion

Treatment:

Drug: BYL719

Drug: LSZ102