Publications by authors named "B Ploeger"
Article Synopsis
- A phase Ib study investigated the safety, maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of regorafenib when combined with vincristine and irinotecan for treating kids with relapsed/refractory solid tumors, primarily rhabdomyosarcoma.
- The study involved 21 patients, determining the MTD/RP2D of regorafenib at 82 mg/m2 when given sequentially; adverse effects mostly included severe blood-related issues, with varying levels of response observed in tumors.
- Findings suggest that regorafenib can be safely combined with vincristine and irinotecan in pediatric settings, showing promising clinical activity for certain types of tumors.
Background: Anti-programmed cell death protein 1 antibodies plus multikinase inhibitors have shown encouraging activity in several tumour types, including colorectal cancer. This study assessed regorafenib plus nivolumab in patients with microsatellite stable/mismatch repair-proficient metastatic colorectal cancer.
Methods: This single-arm, open-label, multicentre phase 2 study enrolled adults from 13 sites in the USA with previously treated advanced microsatellite stable/mismatch repair-proficient metastatic colorectal cancer.
Vilaprisan is a highly potent selective progesterone receptor modulator in development for the treatment of symptomatic uterine fibroids and endometriosis. Its pharmacokinetics are characterized by rapid absorption, almost complete bioavailability, and dose-proportional exposure. The intrinsic factors of age, bodyweight, and race have no clinically relevant effect on the pharmacokinetics and pharmacodynamics of vilaprisan and do not warrant a dose adjustment.
View Article and Find Full Text PDFPoint-of-care testing in out-of-hospital cardiac arrest: a retrospective analysis of relevance and consequences.
Scand J Trauma Resusc Emerg Med
August 2021
Background: Metabolic and electrolyte imbalances are some of the reversible causes of cardiac arrest and can be diagnosed even in the pre-hospital setting with a mobile analyser for point-of-care testing (POCT).
Methods: We conducted a retrospective observational study, which included analysing all pre-hospital resuscitations in the study region between October 2015 and December 2016. A mobile POCT analyser (Alere epoc®) was available at the scene of each resuscitation.
Assessment of the safe and efficacious dose of the selective progesterone receptor modulator vilaprisan for the treatment of patients with uterine fibroids by exposure-response modelling and simulation.
Br J Clin Pharmacol
February 2022
Aims: We report population pharmacokinetic (popPK) and exposure-response (E-R) analyses for efficacy (induced amenorrhoea [IA]) and safety (unbound oestradiol [E2] concentrations) of the selective progesterone receptor modulator vilaprisan. Results were used to inform the dose for the Phase 3 programme in patients with uterine fibroids.
Methods: A popPK model was developed using data from Phase 1 and 2 studies (including ASTEROID 1 and 2).