Kristeleit, Rebecca
Evans, Jeffry
Molife, L. Rhoda
Tunariu, Nina
Shaw, Heather
Slater, Sarah
Haris, Noor R. Md
Brown, Nicholas F.
Forster, Martin D.
Diamantis, Nikolaos
Rulach, Robert
Greystoke, Alastair
Asghar, Uzma
Rata, Mihaela
Anderson, Stephanie
Bachmann, Felix
Hannah, Alison
Kaindl, Thomas
Lane, Heidi A.
Larger, Patrice J.
Schmitt-Hoffmann, Anne
Engelhardt, Marc
Tzankov, Alexandar
Plummer, Ruth
Lopez, Juanita
Funding for this research was provided by:
Basilea Pharmaceutica (N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A)
Article History
Received: 28 October 2019
Revised: 29 June 2020
Accepted: 16 July 2020
First Online: 3 August 2020
Ethics approval and consent to participate
: Prior to the study, ethics committee and institutional review board approval were obtained from the East of England (Essex) Research Ethics Service (Approval number 11/EE/0092). All patients provided written informed consent prior to study participation. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.
: The study data for this trial are considered commercially proprietary and are not available for unrestricted access. All the authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
: R.K. holds a consulting agreement with Basilea Pharmaceutica International Ltd, outside of the submitted work that is not related to this compound. All Principal Investigators (R.K., J.L., R.P., J.E.) report receiving institutional reimbursement of clinical trial costs from Basilea Pharmaceutica International Ltd during the conduct of the study. J.E. is co-editor of the Clinical Subjects section of the <i>British Journal of Cancer</i>. A.G. is an Editorial Board Member of the <i>British Journal of Cancer</i>. S.A., F.B., T.K., H.L., P.J.L., A.S.-H., and M.E. are past or present employees of Basilea Pharmaceutica International Ltd and hold stock options. A.H. reports personal fees from Basilea Pharmaceutica International Ltd. during the conduct of the study. No potential conflicts of interest were disclosed by the other authors.
: This study and editorial assistance for the preparation of this manuscript were supported by Basilea Pharmaceutica International Ltd. The study teams at the participating sites received infrastructure support from the ECMC (Experimental Cancer Medicine Centre) network, funded by Cancer Research UK, National Institute for Health Research including the NIHR/Wellcome UCL Clinical Research Facility, UCH/UCL Biomedical Research Centre and the Chief Scientist Office (Scotland).