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Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer (AMEERA-1)

Study Overview

Primary Objectives:

Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with palbociclib)

  • To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859 based on the dose-limiting toxicity (DLT) observance in monotherapy (Part A), and in combination with palbociclib (Part C)

Dose Expansion: Part B (SAR439859 monotherapy)

  • To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy

Dose Expansion: Part D (combination of SAR439859 with palbociclib)

  • Overall safety profile of SAR439859 in combination with palbociclib

Midazolam Drug-Drug Interaction Sub-Study: Part E

  • To assess the effect of SAR439859 on CYP3A enzyme activity using midazolam as a probe

Secondary Objectives:

  • Overall safety profile of SAR439859 as monotherapy (Parts A, B, E), and in combination with palbociclib (Parts C, D)
  • Pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A, B, E), and of SAR439859 in combination with palbociclib (Parts C, D), and of palbociclib in combination with SAR439859 (Parts C, D)
  • Antitumor activity of SAR439859 as monotherapy (Part A and E), and in combination with palbociclib (Part C and D) as well as the Clinical Benefit Rate (CBR: Complete Response [CR], Partial Response [PR] and Stable Disease [SD] =24 weeks) in Parts A, B, C, D and E
  • ORR and CBR (CR, PR and SD =24 weeks) in Parts B, D and E according to the estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) at baseline and in treatment
  • Time to first tumor response (CR or PR) in Parts B and D
  • Residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A)
  • To assess potential induction/inhibition effect of SAR439859 on CYP3A (Part A, B, E)

Study Description

A Phase 1/2 study for the safety, efficacy, pharmacokinetic and pharmacodynamics evaluation of SAR439859, administered orally as monotherapy, then in combination with palbociclib in postmenopausal women with estrogen receptor-positive advanced breast cancer

  • ClinicalTrials.gov Identifier: NCT03284957
  • Protocol Number: 17-371

Recruitment Status

Open

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