Pharmacokinetic Considerations for Organ Dysfunction Clinical Trials in Early Drug Development

A Azaro, ME Demirhan, J Lim, J Rodon - Phase I Oncology Drug …, 2020 - Springer
It is not infrequent that patients with different cancers are affected by bodily organ
dysfunction. Factors such as comorbidities, prior anticancer therapies and tumor-related …

[HTML][HTML] Harmonization on renal function assessment is needed during early clinical development of oncology drugs

MA Rudek, RA Graham, MJ Ratain - Journal of clinical oncology …, 2016 - ncbi.nlm.nih.gov
As with other therapeutic areas, the need to understand the disposition of antineoplastic
drugs in patients who have hepatic and renal dysfunction is paramount during drug …

Organ Dysfunction Trials: Background, Historical Barriers, Progress in Overcoming Barriers, and Suggestions for Future Trials

S Kummar, SP Ivy, PJ Harris - Handbook of Anticancer Pharmacokinetics …, 2014 - Springer
In the past, patients with cancer, who also have hepatic or renal dysfunction, have carried a
triple burden. Not only have they suffered from cancer and organ dysfunction, but until …

[PDF][PDF] Harmonization of renal function assessment is needed throughout the whole process of anticancer drug development

C Porta, L Cosmai, M Gallieni, MA Perazella - J Clin Oncol, 2016 - researchgate.net
TO THE EDITOR: The article by Beumer et al 1 addressed the effect of renal impairment on
the toxicity of anticancer compounds tested in phase I trials over three decades, and the …

A survey of renal impairment pharmacokinetic studies for new oncology drug approvals in the USA from 2010 to early 2015: a focus on development strategies and …

JJ Xiao, JS Chen, BL Lum, RA Graham - Anti-Cancer Drugs, 2017 - journals.lww.com
Abstract The US Food and Drug Administration (FDA) issued a guidance document in 2010
on pharmacokinetic (PK) studies in renal impairment (RI) on the basis of observations that …

Dose recommendations for anticancer drugs in patients with renal or hepatic impairment

SD Krens, G Lassche, FGA Jansman… - The Lancet …, 2019 - thelancet.com
Renal or hepatic impairment is a common comorbidity for patients with cancer either
because of the disease itself, toxicity of previous anticancer treatments, or because of other …

Chapter 1: Evaluation of kidney function in patients undergoing anticancer drug therapy, from clinical practice guidelines for the management of kidney injury during …

S Muto, T Matsubara, T Inoue, H Kitamura… - International Journal of …, 2023 - Springer
The prevalence of CKD may be higher in patients with cancer than in those without due to
the addition of cancer-specific risk factors to those already present for CKD. In this review …

International consensus guideline for anticancer drug dosing in kidney dysfunction (ADDIKD): A standardized approach to assessing kidney function in cancer …

G Sandhu, J Adattini, N O'Neill, E Armstrong Gordon… - 2022 - ascopubs.org
e13518 Background: Anticancer drug dosing recommendations in kidney dysfunction are
often empirical, based on non-standardised creatinine assays calculated via the Cockcroft …

[PDF][PDF] Do We Have the Right Dose? Dose Adjustments for Organ Dysfunction

MA Rudek - Chemotherapy, 2012 - pdfs.semanticscholar.org
Cancer patients with adequate hepatic or renal function are typically studied in clinical trials.
Since most anticancer agents are cleared via hepatic or renal mechanisms, dose …

Heterogeneity in methods for estimating renal function in anticancer drug development.

AB Karol, Y Fujiwara, R Paredes, A Argulian, H Joshi… - 2024 - ascopubs.org
e23002 Background: Accurate assessment of renal function is critical in oncology clinical
trials. Many anti-cancer agents are renally excreted or cleared, and impaired kidney function …