van Geel, Robin M. J. M.
van Brummelen, Emilie M. J.
Eskens, Ferry A. L. M.
Huijberts, Sanne C. F. A.
de Vos, Filip Y. F. L.
Lolkema, Martijn P. J. K.
Devriese, Lot A.
Opdam, Frans L.
Marchetti, Serena
Steeghs, Neeltje
Monkhorst, Kim
Thijssen, Bas
Rosing, Hilde
Huitema, Alwin D. R.
Beijnen, Jos H.
Bernards, René
Schellens, Jan H. M.
Article History
Received: 12 November 2019
Revised: 10 February 2020
Accepted: 17 February 2020
First Online: 9 March 2020
Ethics approval and consent to participate
: The study was approved by the accredited Medical Ethics Committee of the NKI-AVL. All substantial protocol amendments were also approved by the same Medical Ethics Committee. The principles of the Declaration of Helsinki and the Medical Research Involving Human Subject Act (WMO) have been followed in this protocol and it is compliant to ICH-GCP. Patients were registered by the trial office of the NKI-AVL after informed consent is given. The study was registered at ClinicalTrials.gov (NCT02039336).
: Neither the whole nor any part of the results of the study carried out under this protocol will be published or passed onto any third party without written consent of the sponsor of this study. All authors of this paper and the involved pharmaceutical companies gave consent for publication.
: The clinical datasets analysed during this clinical trial are available from the corresponding author on reasonable request, and only if anonymisation of patient data can be fully ensured.
: J.B. and J.S. (partly) hold a patent on oral taxane formulations, are shareholders and part-time employees of Modra Pharmaceuticals, a spin-out company developing oral taxanes not related to the paper. All other authors declare that they have no competing interests related to this study.
: Pfizer Inc. funded this study and provided the investigational drugs dacomitinib and PD-0325901.