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Article History

Received: 24 October 2019

Revised: 21 December 2019

Accepted: 15 January 2020

First Online: 10 February 2020

Ethics approval and consent to participate

: Subjects were accrued at Roswell Park Comprehensive Cancer Centre, Cleveland Clinic Taussig Cancer Institute and University Hospitals of Cleveland. The RPCI IRB approved the study protocol on 9 November 2012 (Study # I 229112), the University Hospitals of Cleveland IRB on 24 March 2014 (Study # RPCI 1213) and the Cleveland Clinic Taussig Cancer Institute IRB on 5 November 2014 (Study # 14-1373). The study was conducted according to the principles of the Declaration of Helsinki, the International Conference on Harmonisation and the Guidelines for Good Clinical Practice. All patients provided written informed consent. The trial was registered with ClinicalTrials.gov (NCT01835223).

: Not applicable.

: Data can be available upon request.

: C.F.: AstraZeneca (consultation, fees paid to institute, outside the scope of submitted work).

: This study was approved and funded by the National Comprehensive Cancer Network (NCCN) Oncology Research Programme from general research support provided by AVEO Pharmaceuticals, Inc. This work was partially supported by grants from the National Cancer Institute (NCI) grant P30CA016056 involving the use of Roswell Park Comprehensive Cancer Centre’s Pathology Network Shared Resource and Bioanalytics, Metabolomics and Pharmacokinetics (BMPK) Shared Resource and the National Centre for Research Resources grant S10OD019977.