A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

NCT01985191 ↗

Phase 1 Completed 26 enrolled Sanofi Merck KGaA, Darmstadt, Germany · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary Objectives: To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors. To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors. Secondary Objectives: To characterize the pharmacokinetic profile of SAR405838 and pimasertib. To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib. To characterize genetic status in tumor tissue and circulating tumor DNA.

Timeline

Start: 2013-11
Primary completion: 2016-02
Completion: 2016-02

Publications

de Weger VA, de Jonge M, Langenberg MHG, Schellens JHM, Lolkema M, Varga A, Demers B, Thomas K, Hsu K, Tuffal G, Goodstal S, Mace S, Deutsch E. A phase I study of the HDM2 antagonist SAR405838 combined with the MEK inhibitor pimasertib in patients with advanced solid tumours. Br J Cancer. 2019 Feb;120(3):286-293. doi: 10.1038/s41416-018-0355-8. Epub 2018 Dec 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pimasertib	Small molecule	45 mg	Oral
Subject	Pimasertib	Small molecule	60 mg	Oral
Subject	SAR405838	Small molecule	200 mg	Oral
Subject	SAR405838	Small molecule	300 mg	Oral

A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

Summary

Timeline

Publications

Drugs

Indications