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

Phase 1TerminatedNCT02734615

Novartis Pharmaceuticals199 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

199

Conditions

Advanced or Metastatic ER+ Breast Cancer

Interventions

LSZ102DRUG

LSZ102

LEE011DRUG

LEE011

BYL719DRUG

BYL719

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Massachusetts General Hospital Massachusetts General Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

MD Anderson Cancer Center SC - LSZ102X2101

Houston, Texas, United States

Outcomes

Primary Outcomes

Incidence of dose limiting toxicities (DLTs)

The dose escalation part of the study will be guided by well-established statistical methods/models to estimate the maximum tolerated doses (MTD)and/or recommended doses for expansion (RDE). Safety, pharmacokinetic and pharmacodynamics data will guide dose escalation decisions.

Time frame: Day 1 - Day 28 of Cycle 1 (28 day cycle)

Safety and tolerability of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719

Incidence and severity of adverse events, serious adverse events, clinical laboratory values, vital signs, ECGs, dose interruptions, dose reductions and dose intensity.

Time frame: Approximately 3 years

Secondary Outcomes

Overall response rate (ORR)

Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719. ORR is defined as the proportion of patients with a best overall response of complete response or partial response.

Time frame: Approximately 3 years

Duration of Response (DOR)

Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719

Time frame: 3 years

Progression Free Survival (PFS)

Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719

Time frame: 3 years

Disease control rate (DCR)

Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719

Time frame: 3 years

Plasma concentration of study medications

Data from ClinicalTrials.gov

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