Robbrecht, Debbie G. J.
Lopez, Juanita
Calvo, Emiliano
He, Xiaomin
Hiroshi, Hirai
Soni, Nital
Cook, Natalie http://orcid.org/0000-0003-2606-1082
Dowlati, Afshin
Fasolo, Angelica
Moreno, Victor http://orcid.org/0000-0001-6099-4236
Eskens, Ferry A. L. M.
de Bono, Johann S.
Article History
Received: 25 May 2020
Revised: 25 August 2020
Accepted: 10 September 2020
First Online: 6 October 2020
Ethics approval and consent to participate
: The study was approved by the local ethics committees of each of the participating centres (Medisch Ethische Toetsings Commissie Erasmus MC, NRES London-Central committee, Comíté Ético de Investigación Clínica HM Hospitales, University Hospitals Cleveland Medical Center Institutional Review Board and Comitato Etico Ospedale San Raffaele-IRCCS, Milano). The study was performed according to the principles defined by the Declaration of Helsinki and Good Clinical Practice guidelines. All patients gave written informed consent prior to any study-related procedure.
: All data supporting the results in this manuscript are available at Taiho Oncology.
: D.G.J.R.: travel expenses: Sanofi; consulting/advisory role: Bayer, Cantargia, Servier, Faron Pharmaceuticals, Merck Sharp & Dohme. J.L.: consulting/advisory role: Basilea, Genmab; research grant funding: Basilea, Genmab, Roche. E.C.: consulting/advisory role: Novartis, Nanobiotix, Janssen-Cilag, PsiOxus Therapeutics, Seattle Genetics, EUSA Pharma, Abbvie, Celgene, AstraZeneca, Guidepoint Global, Roche/Genentech, GLG, Pfizer, Servier, Amcure; leadership: START; Speakers’ Bureau: Novartis, travel/accommodation expenses: Roche/Genentech; relationship investigational therapeutics in oncological sciences, stock and other ownership interests: START, Oncoart Associated, International Cancer Consultants; honorario: HM Hospitales; research funding: AstraZeneca, Novartis, BeiGene, START. X.H.: employer: Taiho Oncology, Inc. H.H.: employer: Taiho Pharmaceutical Co.; stock holder; Otsuka Holdings Co., LTD; patents/royalties/other intellectual property: Taiho Pharmaceutical Co. N.S.: employer: Taiho Oncology, Inc. N.C.: consulting/advisory role: Tarveda Therapeutics, Epigene Therapeutics. A.D. declares no potential conflicts of interest. A.F.: travel/accommodation expenses: Amgen, Roche. V.M.: employer: START; consulting/advisory role: Merck; research funding: Abbvie, ACEA Biosciences, Adaptimmune, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Celgene, Eisai, e-Therapeutics, GlaxoSmithKline, Menarini, Nanobiotix, Novartis, Pfizer, PharmaMar, PsiOxus Therapeutics, Puma Biotechnology, Regeneron, RigonTEC, Roche, Sanfoi, Sierra Oncolog, Synthon, Taiho Pharmaceutical, Takeda, Tesaro, Transgene, Bristol-Myers Squibb, Merck, BeiGene, Janssen; expert testimony: Medscape, Nanobiotix, Bayer; travel/accommodation expenses: Sanofi, Regeneron. F.A.L.M.E.: consulting/advisory role: Merck Serono, Roche, Eisai, Ipsen; travel expenses: Pfizer. J.S.d.B.: consulting/advisory role: AstraZeneca, Sanofi, Genentech/Roche, Astellas, Bayer Pharma, Merck Sharp & Dohme, Merck Serono, Boehringer Ingelheim, Sierra Oncology, Menarini Silicon Biosystems, Pfizer, Celgene, Taiho Pharmaceutical, Daiichi Sankyo, Janssen Oncology, Genmab, GlaxoSmithKline, Orion Pharma GmbH, Eisai, BioXCel Therapeutics; travel/accommodation expenses: AstraZeneca, Astellas Pharma, GlaxoSmithKline, Orion Pharma GmbH, Sanofi, Genmab, Taiho Pharmaceutical, Qiagen, Vertex; patents/royalties/other intellectual property on Abiraterone Rewards to Inventors, PARP inhibitors and DNA repair defects, targeting of IL23 in prostate cancer, CHK1 inhibitor; honoraria: AstraZeneca, Sanofi, Astellas Pharma, Pfizer, Genentech/Roche, Janssen, Menarini Silicon Biosystems, Daiichi Sankyo, Sierra Oncology, BioExcel; research funding: AstraZeneca, Genentech, Sanofi, Taiho Pharmaceutical, Daiichi Sankyo, Merck Serono, Astex Pharmaceuticals, Merck Sharp & Dohme, Orion Pharma GmbH, GlaxoSmithKline, CellCentric, Celgene, Sierra Oncology, Bayer, MedImmune, Medivation.
: Role of the funding source Taiho Oncology: study concept and design, supplying study drug TAS-119, sharing data. Research at the Christie NHS Foundation Trust was supported by the NIHR Manchester Clinical Research Facility and Manchester Experimental Cancer Medicine Centre award.