Rodon, Jordi
Pérez-Fidalgo, Alejandro
Krop, Ian E.
Burris, Howard
Guerrero-Zotano, Angel
Britten, Carolyn D.
Becerra, Carlos
Schellens, Jan
Richards, Donald A.
Schuler, Martin
Abu-Khalaf, Maysa
Johnson, Faye M.
Ranson, Malcolm
Edenfield, Jeff
Silva, Antonio P.
Hackl, Wolfgang
Quadt, Cornelia
Demanse, David
Duval, Vincent
Baselga, Jose
Funding for this research was provided by:
Novartis Pharmaceuticals Corporation
Article History
Received: 26 April 2018
Accepted: 25 May 2018
First Online: 7 June 2018
Compliance with ethical standards
:
: J. Rodon reports grants and personal fees from Novartis during the conduct of the study; grants from Bayer and personal fees from Peptomyc, Orion, and Servier outside the submitted work. I. Krop reports personal fees from Genentech/Roche, Daiichi/Sankyo and Macrogenics outside the submitted work; research grants from Genentech/Roche. H. Burris reports other fees Novartis during the conduct of the study. C. Britten reports grants from Novartis during the conduct of the study; grants from Amgen, Boston Biomedical, Eli Lilly, Five Prime, Plexxikon, Keystone Nano, EMD Serono, Roche, Tesaro, Regeneron, Pfizer and Halozyme outside the submitted work; non-financial support from Five Prime; personal fees from Cleave outside the submitted work. M. Schuler reports other fees from University Hospital Essen, University Duisburg-Essen and Ruhrlandklinik outside the submitted work; personal fees from AstraZeneca, Celgene, Roche, Abbvie, Eli Lilly, Alexion, and MSD outside the submitted work; personal fees and grants from Boehringer Ingelheim, Bristol-Myers Squibb, and Novartis outside the submitted work. M. Abu-Khalaf reports grants from Novartis during the conduct of the study and outside the submitted work. A. Silva is employee of Novartis Pharma AG and hold Novartis stock options. W. Hackl is employee of Novartis Pharma AG and hold Novartis stock options. C. Quadt is employee of Novartis Pharma AG and hold Novartis stock options. D. Demanse is employee of Novartis Pharma AG. V. Duval is employee of Novartis Pharma AG. A. Pérez-Fidalgo, A. Guerrero-Zotano, C. Becerra, sJ. Schellens, D. Richards, F. Johnson, M. Ranson, J. Edenfield and J. Baselga have nothing to disclose.
: This study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. An independent ethics committee and institutional review boards approved the study protocol and any subsequent amendments at each participating center. A study steering committee monitored study conduct in line with the protocol.
: Written informed consent was obtained from all individual participants included in the study.