Phase I and pharmacokinetic study of romidepsin in patients with cancer and hepatic dysfunction: a National Cancer Institute Organ Dysfunction Working Group Study

RM Connolly, E Laille, U Vaishampayan, V Chung… - … Cancer Research, 2020 - AACR
… bile, and as such patients with impaired hepatic function were … dosing in patients with cancer
with hepatic dysfunction was … for pharmacologic analysis.) during the conduct of the study. …

The effect of hepatic impairment on outcomes in phase I clinical trials in cancer subjects

AS Mansfield, MA Rudek, D Vulih, GL Smith… - … Cancer Research, 2016 - AACR
Organ Dysfunction Working Group's hepatic impairment categorization and two drug-induced
liver … scores of hepatic function, such as the Model for End-Stage Liver Disease or Child–…

[HTML][HTML] Treatment options for metastatic colorectal cancer in patients with liver dysfunction due to malignancy

L Faugeras, A Dili, A Druez, B Krug, C Decoster… - … reviews in oncology …, 2017 - Elsevier
… very poor and alteration of liver function is … National Cancer Institute Organ Dysfunction
Working Group conducted a phase I study on the pharmacokinetics of oxaliplatin in patients

Risks and benefits of phase I liver dysfunction studies: should patients with severe liver dysfunction be included in these trials?

C Fountzilas, S Stuart, B Hernandez… - Investigational New …, 2017 - Springer
… In our patient population low serum albumin and liver function classification as … of hepatic
impairment. A SWOG early therapeutics committee and NCI organ dysfunction working group

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
… of liver function in patients with different cancers. The severity of … the organ dysfunction,
pharmacokinetics and pharmacology … such as the NCI Organ Dysfunction Working Group (NCI-…

[HTML][HTML] Effect of renal dysfunction on toxicity in three decades of cancer therapy evaluation program–sponsored single-agent phase I studies

JH Beumer, F Ding, H Tawbi, Y Lin, D Viluh… - … of Clinical Oncology, 2016 - ncbi.nlm.nih.gov
… are often excluded because impaired renal function might be … this study, we show that
oncology organ dysfunction studies … of the drug or pharmacologically active metabolite or is a …

… of baseline renal function on safety and early discontinuation of adjuvant capecitabine plus oxaliplatin in elderly patients with resected colon cancer: a multicenter post …

K Yamazaki, S Matsumoto, CK Imamura… - … of Clinical Oncology, 2020 - academic.oup.com
oxaliplatin (CAPOX) is a standard treatment for resected colon cancer; however, in patients
with moderate renal impairment, … National Cancer Institute Organ Dysfunction Working Group

[HTML][HTML] Management of hyperbilirubinaemia in pancreatic cancer patients

R Álvarez, A Carrato, J Adeva, I Alés, S Prados… - … Journal of Cancer, 2018 - Elsevier
… kinases to become pharmacologically active. Subsequently, it … Monitoring of liver function
during treatment is recommended … and oxaliplatin could be used in the context of patients with …

Drug dosing in cancer patients with decreased kidney function: a practical approach

B Sprangers, G Sandhu, MH Rosner, P Tesarova… - Cancer Treatment …, 2021 - Elsevier
… primarily metabolized by the liver, they may have pharmacologically active (eg morphine/…
) to dose stratify patients with impaired kidney function being administered oxaliplatin, it was …

[HTML][HTML] Estimation of kidney function in oncology: implications for anticancer drug selection and dosing

MA Casal, TD Nolin, JH Beumer - … Journal of the American Society …, 2019 - ncbi.nlm.nih.gov
… W, Grem JL; National Cancer Institute Organ Dysfunction Working Group Study: Dose-escalating
and pharmacological study of oxaliplatin in adult cancer patients with impaired renal …