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

Official Title

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

Summary:

To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumour 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.

Trial Description

Primary Outcome:

  • Incidence of dose limiting toxicities (DLTs)
  • Safety and tolerability of LSZ102 and LSZ102 + LEE011 at the recommended dose for expansion (during dose expansion)
Secondary Outcome:
  • Overall response rate (ORR)
  • Duration of Response (DOR)
  • Progression Free Survival (PFS)
  • Disease control rate (DCR)
  • Plasma concentration of study medications
  • Plasma concentration under fasted condition and fed condition
  • Levels of Pharmacodynamic marker Estrogen receptor (ER)
  • Levels of Pharmacodynamic marker Progesterone receptor (PgR)
  • Levels of Pharmacodynamic marker pS6
  • Pharmacokinetics (PK) parameter AUC
  • PK parameter Cmax
  • PK parameter Tmax
  • PK parameter Cmin
  • Levels of Pharmacodynamic marker nucleic acid (e.g. RNA)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society