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Clinical Trial Summary

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)


Clinical Trial Description

Duration of the study, per patient, will include eligibility period (screening period) of up to 4 weeks (28 days), treatment period (at least 1 cycle [28 days] of study treatment), and end of treatment (EOT) visit after the last study treatment administration (i.e. at least 30 days post last treatment or until the patient receives another anticancer therapy, whichever is earlier). The expected enrollment period is approximately 26 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03284957
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-Us@sanofi.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 8, 2017
Completion date September 17, 2020

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