Do, Khanh T. https://orcid.org/0000-0002-9411-8899
Manuszak, Claire
Thrash, Emily
Giobbie-Hurder, Anita
Hu, Jiani
Kelland, Sarah
Powers, Allison
de Jonge, Adrienne
Shapiro, Geoffrey I.
Severgnini, Mariano
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 30 December 2020
Accepted: 4 March 2021
First Online: 20 March 2021
Declarations
:
: KTD has served as a consultant/advisory board member Seattle Genetics and QED Therapeutics; consulting fees from Jackson Laboratories; and has received commercial research grants (to institution) from Eli Lilly. CM is an employee of Moderna Therapeutics at the time of this submission. ET is an employee of Fluidigm at the time of this submission. GIS has received research funding from Eli Lilly, Merck KGaA/EMD-Serono, Merck, and Sierra Oncology. He has served on advisory boards for Pfizer, Eli Lilly, G1 Therapeutics, Roche, Merck KGaA/EMD-Serono, Sierra Oncology, Bicycle Therapeutics, Fusion Pharmaceuticals, Cybrexa Therapeutics, Astex, Almac, Ipsen, Bayer, Angiex, Daiichi Sankyo, Seattle Genetics, Boehringer Ingelheim, ImmunoMet, Asana, Artios, Atrin, and Concarlo Holdings. In addition, he holds a patent entitled, “Dosage regimen for sapacitabine and seliciclib,” also issued to Cyclacel Pharmaceuticals, and a pending patent, entitled, “Compositions and Methods for Predicting Response and Resistance to CDK4/6 Inhibition,” together with Liam Cornell. SK, AP, AA, JH, AG-H, and MS declare no relevant financial or non-financial interests to disclose.
: This study was conducted in accordance with the International Conference on Harmonization, Good Clinical Practice guidelines, and the ethical principles outlined in the Declaration of Helsinki 2008. The study protocol, any amendments, informed consent, and other information that required pre-approval were reviewed and approved by the Institutional Review Board, in accordance with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice and applicable country-specific requirements, including US 21 Code of Federal Regulations 312.3(b) for constitution of independent ethics committees.
: All participants provided written informed consent prior to study entry.