Ameratunga, Malaka
BraƱa, Irene http://orcid.org/0000-0002-1068-9601
Bono, Petri
Postel-Vinay, Sophie
Plummer, Ruth
Aspegren, John
Korjamo, Timo
Snapir, Amir
de Bono, Johann S
Article History
Received: 8 April 2020
Revised: 29 June 2020
Accepted: 14 July 2020
First Online: 29 September 2020
Ethics approval and consent to participate
: The protocol was approved by the institutional review boards and independent ethics committees of the participating centres and registered under the NCT03035591 identifier at the clinicaltrials.gov website. The study was performed in accordance with the Declaration of Helsinki and was conducted in compliance with the International Conference on Harmonization on Good Clinical Practice and written informed consent was required from all patients prior to enrolment.
: The datasets generated and/or analysed during the current study are not publicly available due proprietary restrictions but are available from the corresponding author on reasonable request.
: All authors have completed the Unified Competing Interest form (ExternalRef removed) and declare: I.B. reports scientific consultancy role for Orion Pharma. P.B. reports personal fees from Orion Pharma, during the conduct of the study; personal fees from BMS, MSD, Pfizer, Novartis, Oncorena, TILT Biotherapeutics, Faron Pharmaceuticals, Ipsen, Herantis Pharma, outside the submitted work; and stock ownership: TILT Biotherapeutics and Terveystalo. S.P-V. has received research funding from Merck KGaA, Boehringer Ingelheim and Institut Roche for unrelated research projects. SPV has participated to advisory boards for Merck KGaA. As part of the Drug Development Department (DITEP), SPV is principal investigator or sub-investigator of clinical trials from Abbvie, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Arno Therapeutics, Astex Pharmaceuticals, Astra Zeneca, Aveo, Bayer Healthcare Ag, Bbb Technologies Bv, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corporation, Chugai Pharmaceutical Co., Clovis Oncology, Daiichi Sankyo, Debiopharm S.A., Eisai, Eli Lilly, Exelixis, Forma, Gamamabs, Genentech, Inc., Glaxosmithkline, H3 Biomedicine, Inc, Hoffmann La Roche Ag, Innate Pharma, Iris Servier, Janssen Cilag, Kyowa Kirin Pharm. Dev., Inc., Loxo Oncology, Lytix Biopharma As, Medimmune, Menarini Ricerche, Merck Sharp & Dohme Chibret, Merrimack Pharmaceuticals, Merus, Millennium Pharmaceuticals, Nanobiotix, Nektar Therapeutics, Novartis Pharma, Octimet Oncology Nv, Oncoethix, Onyx Therapeutics, Orion Pharma, Oryzon Genomics, Pfizer, Pharma Mar, Pierre Fabre, Roche, Sanofi Aventis, Taiho Pharma, Tesaro Inc, and Xencor. R.P. reports other from Celgene, during the conduct of the study. J.A., T.K. and A.S. are employees of Orion Corporation Orion Pharma. J.DB. has served on advisory boards and received fees from many companies including Astra Zeneca, Astellas, Bayer, Boehringer Ingelheim, Cellcentric, Daiichi, Genentech/Roche, Genmab, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Menarini/Silicon Biosystems, Orion, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Vertex Pharmaceuticals. He is an employee of The ICR, which have received funding or other support for his research work from AZ, Astellas, Bayer, Cellcentric, Daiichi, Genentech, Genmab, GSK, Janssen, Merck Serono, MSD, Menarini/Silicon Biosystems, Orion, Sanofi Aventis, Sierra Oncology, Taiho, Pfizer, Vertex, and which has a commercial interest in abiraterone, PARP inhibition in DNA repair defective cancers and PI3K/AKT pathway inhibitors (no personal income). He was named as an inventor, with no financial interest, for patent 8,822,438. He has been the CI/PI of many industry sponsored clinical trials. JDB is a National Institute for Health Research (NIHR) Senior Investigator. The views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health. The remaining authors declare no competing interests.
: The study was sponsored by Orion Corporation, Orion Pharma, Espoo, Finland, the developer of ODM-207.