Phase 1 Safety Testing of SAR405838

Summary

Primary Objectives: * To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). * To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: * Pharmacokinetic (PK) profile of SAR405838. * Biomarkers in association with SAR405838. * Anti-tumor activity in response to SAR405838. * Food effect on SAR405838 PK. * Compliance with SAR405838 treatment. * Cytochrome P450 3A4/5 (CYP3A4/5) activity.

Timeline

Start

2012-07-13

Primary completion

2018-03-05

Completion

2018-03-05

Publications

• de Jonge M, de Weger VA, Dickson MA, Langenberg M, Le Cesne A, Wagner AJ, Hsu K, Zheng W, Mace S, Tuffal G, Thomas K, Schellens JH. A phase I study of SAR405838, a novel human double minute 2 (HDM2) antagonist, in patients with solid tumours. Eur J Cancer. 2017 May;76:144-151. doi: 10.1016/j.ejca.2017.02.005. Epub 2017 Mar 17.

Drugs

Indications