Miller, Todd W.
Traphagen, Nicole A.
Li, Jing
Lewis, Lionel D.
Lopes, Beatriz
Asthagiri, Ashok
Loomba, Johanna
De Jong, Jenny
Schiff, David
Patel, Sohil H.
Purow, Benjamin W.
Fadul, Camilo E. http://orcid.org/0000-0001-7459-7661
Clinical trials referenced in this document:
Documents that mention this clinical trial
Tumor pharmacokinetics and pharmacodynamics of the CDK4/6 inhibitor ribociclib in patients with recurrent glioblastoma
https://doi.org/10.1007/s11060-019-03258-0
6ER-004 Preliminary clinical response of ribociclib as a single agent in advanced breast cancer: in search of new therapeutic indications
https://doi.org/10.1136/ejhpharm-2020-eahpconf.439
Funding for this research was provided by:
Novartis Pharmaceuticals
Norris Cotton Cancer Center
Radiologic Society of North America (RSCH1819)
Article History
Received: 13 May 2019
Accepted: 2 August 2019
First Online: 9 August 2019
Compliance with ethical standards
:
: The University of Virginia (CEF) received research funding from Novartis Pharmaceuticals to conduct this clinical study. All other authors declare that they have no conflicts of interest.
: This study (NCT02345824) was approved by the local Institutional Review Board for Health Sciences Research (IRB approval #18729), was conducted in accordance with Good Clinical Practice, and was monitored by the Data Safety and Monitoring Committee of the University of Virginia Cancer Center. The FDA (IND #125168) approved the IND application for this study. Informed consent was obtained from all individual participants included in the study, prior to performing any study related procedures. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.