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Article History

Received: 24 January 2020

Accepted: 16 March 2020

First Online: 27 March 2020

Compliance with ethical standards

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: AJ, HS, and AB are employed by Merck KGaA, Darmstadt, Germany, which is developing tepotinib. MM and PW were employed by Merck KGaA, Darmstadt, Germany, when the study was conducted. JJvL is employed by PRA, which was contracted by Merck KGaA, Darmstadt, Germany, to conduct parts of the reported research. Tepotinib is currently under clinical investigation and has not been approved by any regulatory authority.

: This study was conducted in accordance with the principles of the Declaration of Helsinki, in compliance with the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP) [], and was compliant with the European Union Clinical Trial Directive (EU CTD) []. The study protocol and the informed consent form (ICF) were approved by the Independent Ethics Committee for Clinical Pharmacology of the Foundation Beoordeling Ethiek Biomedisch Onderzoek (‘Evaluation of the Ethics of Biomedical Research’; Assen, The Netherlands).

: All participants signed the ICF before any trial-related procedures were started. The study was conducted by Pharmaceutical Research Association (PRA) Health Sciences (Zuidlaren, The Netherlands).