Dose selection for the investigational anticancer agent alisertib (MLN8237): Pharmacokinetics, pharmacodynamics, and exposure–safety relationships
K Venkatakrishnan, X Zhou, J Ecsedy… - The Journal of …, 2015 - Wiley Online Library
We report population pharmacokinetic, pharmacodynamic, and pharmacokinetic‐safety
analyses to support phase II/III dose/regimen selection of alisertib, a selective Aurora A …
analyses to support phase II/III dose/regimen selection of alisertib, a selective Aurora A …
[HTML][HTML] Case example of dose optimization using data from bortezomib dose-finding clinical trials
SM Lee, D Backenroth, YKK Cheung… - Journal of Clinical …, 2016 - ncbi.nlm.nih.gov
Purpose The current dose-finding methodology for estimating the maximum tolerated dose
of investigational anticancer agents is based on the cytotoxic chemotherapy paradigm …
of investigational anticancer agents is based on the cytotoxic chemotherapy paradigm …
A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and various degrees …
M Slingerland, D Hess, S Clive, S Sharma… - Cancer chemotherapy …, 2014 - Springer
Purpose To evaluate the pharmacokinetics and safety of oral panobinostat in patients with
advanced solid tumors and varying degrees of hepatic function. Methods Patients with …
advanced solid tumors and varying degrees of hepatic function. Methods Patients with …
A phase I/II adaptive design for heterogeneous groups with application to a stereotactic body radiation therapy trial
NA Wages, PW Read, GR Petroni - Pharmaceutical statistics, 2015 - Wiley Online Library
Dose‐finding studies that aim to evaluate the safety of single agents are becoming less
common, and advances in clinical research have complicated the paradigm of dose finding …
common, and advances in clinical research have complicated the paradigm of dose finding …
Pharmacokinetics and dose escalation of the heat shock protein inhibitor 17-allyamino-17-demethoxygeldanamycin in combination with bortezomib in relapsed or …
AR Walker, R Klisovic, JS Johnston, Y Jiang… - Leukemia & …, 2013 - Taylor & Francis
This phase I study was conducted to determine the maximum tolerated dose (MTD) and
dose limiting toxicities (DLTs) of the heat shock protein 90 (HSP90) inhibitor 17-allyamino …
dose limiting toxicities (DLTs) of the heat shock protein 90 (HSP90) inhibitor 17-allyamino …
The effect of hepatic impairment on outcomes in phase I clinical trials in cancer subjects
AS Mansfield, MA Rudek, D Vulih, GL Smith… - Clinical Cancer …, 2016 - AACR
Abstract Purpose: The NCI Cancer Therapy Evaluation Program sponsors hepatic
dysfunction phase I clinical trials (HDCT) and phase 1 clinical trials (P1CT) to determine safe …
dysfunction phase I clinical trials (HDCT) and phase 1 clinical trials (P1CT) to determine safe …
Population pharmacokinetics of nintedanib, an inhibitor of tyrosine kinases, in patients with non-small cell lung cancer or idiopathic pulmonary fibrosis
U Schmid, KH Liesenfeld, A Fleury, C Dallinger… - Cancer chemotherapy …, 2018 - Springer
Purpose A population pharmacokinetic model was developed for nintedanib in patients with
non-small cell lung cancer (NSCLC) or idiopathic pulmonary fibrosis (IPF). The effects of …
non-small cell lung cancer (NSCLC) or idiopathic pulmonary fibrosis (IPF). The effects of …
QPI Allows in vitro Drug Screening of Triple Negative Breast Cancer PDX Tumors and Fine Needle Biopsies
GF Murray, TH Turner, D Guest, KA Leslie… - Frontiers in …, 2019 - frontiersin.org
The development of resistance to initially successful cancer therapies is a major cause of the
morbidity and mortality associated with cancer. Identifying evolving resistance at an early …
morbidity and mortality associated with cancer. Identifying evolving resistance at an early …
Protein therapeutics: an updated review
A Chakraborty, DK Singha, M Chakraborty… - 2021 - indianjournals.com
Therapeutic protein are one of the prime option of biologicals as per their clinical uses. In
recent times, uses of therapeutic protein increases day by day. Protein therapeutics are used …
recent times, uses of therapeutic protein increases day by day. Protein therapeutics are used …
Isotonic designs for phase I trials in partially ordered groups
M Conaway - Clinical Trials, 2017 - journals.sagepub.com
Background/aims: Dose-finding trials can be conducted such that patients are first stratified
into multiple risk groups before doses are allocated. The risk groups are often completely …
into multiple risk groups before doses are allocated. The risk groups are often completely …