Quantification of the pharmacokinetic-toxicodynamic relationship of oral docetaxel co-administered with ritonavir

Jibodh RA, Lagas JS, Nuijen B, Beijnen JH, Schellens JH (2013) Taxanes: old drugs, new oral formulations. Eur J Pharmacol 717:40–46. https://doi.org/10.1016/j.ejphar.2013.02.058

Moes JJ, Stuurman FE, Hendrikx JJMA, Marchetti S, Huitema AD, Beijnen JH, Schellens JH, Nuijen B (2013) Pharmacokinetic evaluation of three oral formulations of docetaxel boosted with ritonavir: two single-drug formulations vs. a fixed-dose combination tablet. Drug Deliv Transl Res 3:243–251. https://doi.org/10.1007/s13346-012-0127-6

Moes JJ, Koolen SLW, Huitema ADR, Schellens JH, Beijnen JH, Nuijen B (2011) Pharmaceutical development and preliminary clinical testing of an oral solid dispersion formulation of docetaxel (ModraDoc001). Int J Pharm 420:244–250. https://doi.org/10.1016/j.ijpharm.2011.08.041

Sawicki E, Beijnen JH, Schellens JHM, Nuijen B (2016) Pharmaceutical development of an oral tablet formulation containing a spray dried amorphous solid dispersion of docetaxel or paclitaxel. Int J Pharm 511:765–773. https://doi.org/10.1016/J.IJPHARM.2016.07.068

Koolen SLW, Beijnen JH, Schellens JHM (2010) Intravenous-to-oral switch in anticancer chemotherapy: a focus on docetaxel and paclitaxel. Clin Pharmacol Ther 87:126–129. https://doi.org/10.1038/clpt.2009.233

Schellens JH, Malingré MM, Kruijtzer CM, Bardelmeijer HA, van Tellingen O, Schinkel AH, Beijnen JH (2000) Modulation of oral bioavailability of anticancer drugs: from mouse to man. Eur J Pharm Sci 12:103–110

TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion. Summary of product characteristics

Oostendorp RL, Huitema A, Rosing H, Jansen RS, ter Heine R, Keessen M, Beijnen JH, Schellens JH (2009) Coadministration of ritonavir strongly enhances the apparent oral bioavailability of docetaxel in patients with solid tumors. Clin Cancer Res 15:4228–4233. https://doi.org/10.1158/1078-0432.CCR-08-2944

Bardelmeijer HA, Ouwehand M, Buckle T, Huisman MT, Schellens JH, Beijnen JH, van Tellingen O (2002) Low systemic exposure of oral docetaxel in mice resulting from extensive first-pass metabolism is boosted by ritonavir. Cancer Res 62:6158–6164

de Weger VA, Stuurman FE, Hendrikx JJMA, Moes JJ, Sawicki E, Huitema ADR, Nuijen B, Thijssen B, Rosing H, Keessen M, Mergui-Roelvink M, Beijnen JH, Schellens JHM, Marchetti S (2017) A dose-escalation study of bi-daily once weekly oral docetaxel either as ModraDoc001 or ModraDoc006 combined with ritonavir. Eur J Cancer 86:217–225. https://doi.org/10.1016/j.ejca.2017.09.010

de Weger VA, Stuurman FE, Koolen SL, et al (2019) A phase I dose escalation study of once weekly oral administration of docetaxel as ModraDoc001 capsule or ModraDoc006 tablet in combination with ritonavir. Clin Cancer Res Epub ahead:Epub ahead of print. https://doi.org/10.1158/1078-0432.CCR-17-229912.

Ho M, Mackey J (2014) Presentation and management of docetaxel-related adverse effects in patients with breast cancer. Cancer Manag Res 6:253. https://doi.org/10.2147/CMAR.S40601

de Vries Schultink AHM, Suleiman AA, Schellens JHM, Beijnen JH, Huitema AD (2016) Pharmacodynamic modeling of adverse effects of anti-cancer drug treatment. Eur J Clin Pharmacol 72:645–653. https://doi.org/10.1007/s00228-016-2030-4

van Hasselt JGC, Gupta A, Hussein Z, Beijnen JH, Schellens JH, Huitema AD (2013) Population pharmacokinetic-pharmacodynamic analysis for eribulin mesilate-associated neutropenia. Br J Clin Pharmacol 76:412–424. https://doi.org/10.1111/bcp.12143

Zandvliet AS, Schellens JHM, Beijnen JH, Huitema ADR (2008) Population pharmacokinetics and pharmacodynamics for treatment optimization in clinical oncology. Clin Pharmacokinet 47:487–513. https://doi.org/10.2165/00003088-200847080-00001

Zhang L, Beal SL, Sheiner LB (2003) Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn 30:387–404

Yu H, Janssen JM, Sawicki E, et al (2019) A population pharmacokinetic model of Oral Docetaxel Coadministered with ritonavir to support early clinical Development. J Clin Pharmacol jcph.1532. https://doi.org/10.1002/jcph.1532

van Brummelen EMJ, Huitema ADR, van Werkhoven E et al (2016) The performance of model-based versus rule-based phase I clinical trials in oncology: a quantitative comparison of the performance of model-based versus rule-based phase I trials with molecularly targeted anticancer drugs over the last 2 years. J Pharmacokinet Pharmacodyn 43:1–8. https://doi.org/10.1007/s10928-016-9466-0

Keizer RJ, van Benten M, Beijnen JH, Schellens JH, Huitema AD (2011) Pirana and PCluster: a modeling environment and cluster infrastructure for NONMEM. Comput Methods Prog Biomed 101:72–79. https://doi.org/10.1016/j.cmpb.2010.04.018

Beal SL, Boeckman AJ, Sheiner LB (1988) NONMEM user guides

Development Core Team R (2008) R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria