Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
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
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); Part D (combination SAR439859 with palbociclib) - To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy (Part B), and in combination with palbociclib (Part D) Secondary Objectives: - To characterize the overall safety profile of SAR439859 as monotherapy (Parts A and B), and in combination with palbociclib (Parts C and D) - To characterize the pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A and B), and of SAR439859 in combination with palbociclib (Parts C and D), as well as of palbociclib in combination with SAR439859 (Parts C and D) - To evaluate antitumor activity of SAR439859 as monotherapy (Part A), and in combination with palbociclib (Part C) as well as the disease control rate (DCR) in Parts A, B, C, and D - To evaluate ORR and DCR (Complete Response [CR], Partial Response [PR] and Stable Disease [SD] =6 months) in Parts B and D according to the estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) - To evaluate residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A)
*For Eligibility information, look up the trial at NIH by clicking on the Study Number above.*
Other eligibility criteria may apply.
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