Ryoo, Baek-Yeol
Palmer, Daniel H.
Park, Sook Ryun
Rimassa, Lorenza
Debashis Sarker,
Daniele, Bruno
Steinberg, Joyce
López, Beatriz
Lim, Ho Yeong
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Study of Enzalutamide Versus Placebo in Advanced Hepatocellular Carcinoma
https://doi.org/10.1007/s40261-021-01063-0
Funding for this research was provided by:
This study was funded by Astellas Pharma Inc. and Pfizer Inc., the co developers of enzalutamide.
Article History
Accepted: 15 July 2021
First Online: 5 August 2021
Change Date: 27 February 2022
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s40261-022-01132-y
Declarations
:
: The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. All authors had full access to all of the data in the study and had final responsibility for the decision to submit for publication; they take full responsibility for the scope, direction and content of the manuscript and have approved the submitted manuscript. The authors received no compensation related to the development of the manuscript. Study conception and design: B-YR, JS, and HYL. Material preparation, data collection and analysis: B-YR, DHP, SRP, LR, DS, BD, JS, BL, and HYL. Writing—original draft preparation: LR, JS, BL. Writing—review and editing: B-YR, DHP, SRP, LR, DS, BD, JS, BL, and HYL. Supervision: B-YR, JS.
: Researchers may request access to anonymized participant level data, trial level data and protocols from Astellas sponsored clinical trials at ExternalRef removed. For the Astellas criteria on data sharing see: ExternalRef removed.
: This study was funded by Astellas Pharma Inc. and Pfizer Inc., the co-developers of enzalutamide. The study sponsors were involved in the design and conduct of the study, the collection, management, analysis and interpretation of the data, and the review and approval of the manuscript.
: B.-Y. Ryoo received grants from Astellas Pharma Inc. during the conduct of the study. D.H. Palmer received personal fees from Astellas Pharma Inc. during the conduct of the study; grants and personal fees from Bayer, NuCana, and Sirtex outside the submitted work; and personal fees from BMS, Celgene, Halozyme, and Targovax outside the submitted work. The institution of L. Rimassa received grants from Astellas Pharma Inc. during the conduct of the study; grants from Agios, ARMO Biosciences, AstraZeneca, Beigene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Services, Roche, and Zymeworks outside the submitted work; personal fees from AbbVie, Amgen, ArQule, AstraZeneca, Basilea, Bayer, BMS, Celgene, Eisai, Exelixis, Genenta, Gilead, Hengrui Therapeutics, Incyte, Ipsen, IQVIA, Lilly, Merck Serono, MSD, Nerviano Medical Sciences, Roche, Sanofi and Zymeworks outside the submitted work; and non-financial support from Ipsen outside the submitted work. D. Sarker has received advisory board payments from Eisai, Ipsen, Novartis, and Surface Oncology outside the submitted work; honoraria from the speakers bureaus of AstraZeneca, Bayer, Eisai, Ipsen, MSD, and Pfizer outside the submitted work; and travel payments from Bayer, Eisai, and MiNA Therapeutics outside the submitted work. B. Daniele has received personal fees from Amgen, Astra Zeneca, Bayer, Ipsen, Lilly, MSD, Roche, and Sanofi outside the submitted work; and personal fees and payment for lectures from Eisai outside the submitted work. H.Y. Lim has received consulting fees or honorarium from AstraZeneca, Bayer, BMS, Eisai, and Ipsen outside the submitted work. J. Steinberg is an employee of Astellas Pharma Inc. and B. López was an employee of Astellas Pharma Inc. at the time of the study. S.R. Park reports no conflicts of interest.
: The study was performed in accordance with the Declaration of Helsinki and the International Conference on Harmonisation for Good Clinical Practice Guidelines. The trial protocol, patient information sheets, and consent forms were reviewed and approved by the independent ethics committee and/or institutional review board (IRB) of each participating institution. This study had 37 study sites and 27 approving IRBs; the full list of IRBs can be found in the supplementary material.
: Informed consent was received from each patient prior to any study-related procedures.