[HTML][HTML] Chemotherapy-induced liver injury in children

E Urrutia-Maldonado, A Abril-Molina… - Anales de Pediatría …, 2019 - Elsevier
Introduction Drug-induced liver injury due to chemotherapy is an important cause of
morbidity in cancer patients, although its clinical manifestations are poorly understood …

Clinical implications of drug‐induced liver injury in early‐phase oncology clinical trials

SP Mondaca, D Liu, JR Flynn, S Badson, S Hamaway… - Cancer, 2020 - Wiley Online Library
Background Data on drug‐induced liver injury (DILI) and acute liver failure (ALF) in modern
phase 1 oncology trials are limited, specifically with respect to the incidence and resolution …

Population pharmacokinetics of mirvetuximab soravtansine in patients with folate receptor‐α positive ovarian cancer: The antibody–drug conjugate, payload and …

YP Tu, E Hanze, F Zhu, HM Lagraauw… - British Journal of …, 2024 - Wiley Online Library
Aims Mirvetuximab soravtansine is a first‐in‐class antibody–drug conjugate recently
approved for the treatment of folate receptor‐α positive ovarian cancer. The aim of this study …

Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis

A Soehoel, MS Larsen… - Clinical Pharmacology in …, 2022 - Wiley Online Library
Tralokinumab is the first biologic therapy for moderate‐to‐severe atopic dermatitis (AD) that
specifically neutralizes interleukin‐13 activity, a key driver of AD signs and symptoms …

[PDF][PDF] A review of regulatory guidance for conducting hepatic impairment studies: a case study in oncology

R D'Cunha, S Lin - J Oncol Cancr Res, 2018 - academia.edu
The liver is a vital organ that plays a central role in the metabolism and elimination of drug
molecules. Impairment of this vital organ can lead to increased accumulation of parent drug …

Population Pharmacokinetics and Exposure Response Analysis of Pomalidomide in Subjects With Relapsed or Refractory Multiple Myeloma From the Novel …

Y Li, N Kassir, X Wang, M Palmisano… - The Journal of Clinical …, 2020 - Wiley Online Library
Multiple myeloma is an incurable progressive neoplastic disease that accounts for 10% of all
hematologic malignancies. Even though significant progress has been made in the …

Neratinib Alone or in Combination with Immune Checkpoint Inhibitors with or without mTOR Inhibitors in Patients with Fibrolamellar Carcinoma

GK Abou-Alfa, T Meyer, RKG Do, SA Piha-Paul… - 2024 - karger.com
Introduction: Fibrolamellar carcinoma (FLC) displays upregulation of several oncogenes,
including HER2, and multiple immune-suppressive mechanisms. We investigated the …

Pharmacokinetics of the investigational Aurora A kinase inhibitor alisertib in adult patients with advanced solid tumors or relapsed/refractory lymphoma with varying …

X Zhou, AC Lockhart, S Fu, J Nemunaitis… - The Journal of …, 2019 - Wiley Online Library
This clinical trial was designed to evaluate the effect of moderate or severe hepatic
impairment on the single‐dose pharmacokinetics (PK) of the investigational anticancer …

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
Introduction The goal of organ dysfunction Phase I trials is to characterize the safety and
pharmacokinetics of novel agents in cancer patients with liver or kidney dysfunction, but the …

Role of Clinical Pharmacokinetics Studies in Contemporary Oncology Drug Development

FM Uckun, S Qazi - Drug Discovery and Evaluation: Methods in Clinical …, 2020 - Springer
Pharmacokinetics (PK) studies enable drug developers to elucidate the relationship of dose
to blood concentrations of drugs in various patient populations and determine the need for …