Plummer, Ruth
Dua, Divyanshu
Cresti, Nicola
Drew, Yvette
Stephens, Peter
Foegh, Marie
Knudsen, Steen
Sachdev, Pallavi
Mistry, Bipin M.
Dixit, Vaishali
McGonigle, Sharon
Hall, Nancy
Matijevic, Mark
McGrath, Shannon
Sarker, Debashis
Article History
Received: 27 November 2019
Revised: 14 April 2020
Accepted: 14 May 2020
First Online: 11 June 2020
Ethics approval and consent to participate
: The study was approved by the NRES Committee South Central-Berkshire B, Bristol REC Centre, Whitefriars, Level 3 Block B, Lewins Mead, Bristol BS1 2NT, United Kingdom; REC reference: 11/SC/0377. The study was conducted in full accordance with the principles of the World Medical Association Declaration of Helsinki, the International Conference on Harmonisation and all applicable local guidelines and regulations on good clinical practice. All patients provided written informed consent.
: All patients provided written informed consent about participation in this study and the use of collated data. No individual patient data are included in this article that could be used to identify any individual.
: The data will not be available for sharing at this time as the data are commercially confidential. However, Eisai will consider written requests to share the data on a case-by-case basis.
: Ruth Plummer has received honoraria for attending advisory boards from Pierre Faber, Genmab, Bayer, Octimet, Clovis Oncology, Novartis, Karus Therapeutics, Biosceptre, BMS, Cybrexa, Ellipses and Sanofi Aventis, and for delivery of educational talks or chairing educational meetings by AstraZeneca, Novartis, Bayer, Tesaro and BMS. R.P. is named on the patent of use for rucaparib. Yvette Drew has participated on advisory boards for Clovis Oncology, AstraZeneca, Merck, Tesaro, Inc. and Genmab. Y.D. has received research grant funding from Clovis Oncology, and was involved in the preclinical and clinical development of rucaparib. Newcastle University (Y.D.’s employer) and Y.D. have received royalties for their involvement in the development of rucaparib. Y.D. has received research grant funding from AstraZeneca and Tesaro, Inc. Y.D. is an investigator on clinical trials of olaparib and rucaparib. Marie Foegh and Steen Knudsen are employees of, and have ownership interest in Oncology Venture, which owns rights related to the contents of this article. Pallavi Sachdev, Bipin M. Mistry, Vaishali Dixit, Sharon McGonigle, Nancy Hall, Mark Matijevic and Shannon McGrath are/were full-time employees of Eisai Inc., at the time of the study. Nicola Cresti and Divyanshu Dua have no relevant conflicts of interest to declare. Dr Peter Stephens has received honoraria for serving on advisory boards for Novartis, and educational support from Eisai and Daiichi Sankyo. Dr Debashis Sarker has received honoraria from Pfizer, Bayer and Ipsen, and has had consultancy/advisory roles with Novartis, Ipsen and Eisai.
: This work was supported by Eisai Inc., Woodcliff Lake, NJ, USA. Editorial assistance was provided by Tarah M. Connolly, PhD, of Oxford PharmaGenesis Inc., Newtown, PA, USA, which was funded by Eisai Inc., Woodcliff Lake, NJ, USA. The University of Newcastle and King’s College London receive support from Cancer Research UK and Department of Health (England) as Experimental Cancer Medicine Centres. Financial support for the study was also provided by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) award to Guy’s & St Thomas’ NHS Foundation Trust in partnership with King’s College London and King’s College Hospital NHS Foundation Trust (and NIHR Clinical Research Facility).