Vermunt, Marit A. C. http://orcid.org/0000-0002-2674-1291
de Weger, Vincent A.
Janssen, Julie M.
Lopez-Yurda, Marta I.
Keessen, Marianne
Thijssen, Bas
Rosing, Hilde
Huitema, Alwin D. R.
Beijnen, Jos H.
Marchetti, Serena
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effect of Food on the Pharmacokinetics of the Oral Docetaxel Tablet Formulation ModraDoc006 Combined with Ritonavir (ModraDoc006/r) in Patients with Advanced Solid Tumours
https://doi.org/10.1007/s40268-020-00336-x
Funding for this research was provided by:
Modra Pharmaceuticals BV
Article History
Accepted: 27 December 2020
First Online: 19 January 2021
Declarations
:
: The study was funded and ModraDoc006 tablets provided by Modra Pharmaceuticals BV. Modra Pharmaceuticals is a commercial pharmaceutical company that was founded as a spin-off of the Netherlands Cancer Institute. ModraDoc006/r is currently in clinical development as the lead product of Modra Pharmaceuticals.
: J.H. Beijnen is a (part-time) employee, patent holder and stockholder of Modra Pharmaceuticals BV. Marianne Keessen is a full-time employee of Modra Pharmaceuticals BV. Marit A.C. Vermunt, Vincent A. de Weger, Julie M. Janssen, Marta I. Lopez-Yurda, Bas Thijssen, Hilde Rosing, and Alwin D.R. Huitema Serena Marchetti have no conflicts of interest that are directly relevant to the content of this article.
: The study was approved by the Medical Ethical Committee of the Netherlands Cancer Institute. The study was performed in compliance with current standards of International Conference for Harmonization—Good Clinical Practice and the WHO Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act.
: All patients received written information and an explanation of the study and signed written informed consent before participation in the trial. The informed consent procedure was conducted compliant with current standards of International Conference for Harmonization—Good Clinical Practice.
: Consent for publication was not applicable since all collected data were anonymised before storage, analysis and publication.
: The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
: Not applicable.
: MV, VW, MK, JB and SM contributed to the protocol development and initiation of the trial. MV, VW and SM contributed to the conduct of the clinical trial. MV and VW contributed to the data collection. VW, JJ, BT, HR and AH contributed to the pharmacokinetic analysis. ML contributed to the statistical analysis. The first draft of the manuscript was written by MV. All authors commented on previous versions of and read and approved the final manuscript.