Phase I and Pharmacokinetic Study of Romidepsin in Patients with Cancer and Hepatic Dysfunction: A National Cancer Institute Organ Dysfunction Working Group Study.

Roisin M ConnollyEric LailleUlka VaishampayanVincent ChungKaren KellyAfshin DowlatiOlatunji B Alese Robert Donald HarveyPaul HaluskaLillian L SiuShivaani KummarRichard PiekarzS Percy IvyNicole M AndersMelinda DownsAshley O'ConnorAngela ScardinaJacqueline SaundersGary L RosnerMichelle A Rudeknull null

Published in: Clinical cancer research : an official journal of the American Association for Cancer Research (2020)

Data from the ETCTN-9008 trial led to changes in the romidepsin labeling to reflect starting dose adjustment for patients with cancer and moderate and severe hepatic impairment, with no adjustment for mild hepatic impairment.

Keyphrases

oxidative stress
clinical trial
study protocol
electronic health record
early onset
randomized controlled trial
machine learning
big data
phase ii
deep learning
drug induced
open label