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Authors
Li, Chao
Horton, Janet K.
Sale, Mark
Curd, Laura
Goti, Vineet
Tao, Wenli
Beelen, Andrew https://orcid.org/0000-0001-9732-2089
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Clinical Trials BETA
Clinical trials referenced in this document:
nct02514447 at ClinicalTrials.govDocuments that mention this clinical trial
Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer
https://doi.org/10.1007/s00280-021-04239-9
Pharmacokinetic Drug–Drug Interaction Studies Between Trilaciclib and Midazolam, Metformin, Rifampin, Itraconazole, and Topotecan in Healthy Volunteers and Patients with Extensive-Stage Small-Cell Lung Cancer
https://doi.org/10.1007/s40261-022-01179-x
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Funding
Funding for this research was provided by:
G1 Therapeutics. Inc.
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Article History
Accepted: 21 June 2022
First Online: 16 July 2022
Declarations
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: This research was supported by G1 Therapeutics, Inc.
: Chao Li and Wenli Tao were employees of G1 Therapeutics, Inc. at the time of the study. Andrew Beelen and Janet K. Horton are employees of and report stock ownership in G1 Therapeutics, Inc. Laura Curd and Mark Sale are employees of Nuventra. Vineet Goti is a former employee of Nuventra.
: The studies were conducted in accordance with the principles of the Declaration of Helsinki, the Good Clinical Practice guidelines of the International Council for Harmonisation, and any applicable national and local laws and regulations. The study protocols and informed consent documents were approved by the institutional review board (IRB) or independent ethics committee at each participating site. Study 106 (Midlands IRB [MLIRB], IRB#: 220190105); Study 114 (MLIRB, IRB#: 220190062); Study G1T28-03 (Copernicus Group IRB, Central US approval; Serbia: Ethics Committee of Institute for Pulmonary Diseases of Vojvodina, Ethics Committee of Clinical Center Nis, Ethics Committee of Institute for Oncology and Radiology of Serbia, Ethics Committee of Clinical Center of Serbia, Ethics Committee of Clinical Hospital Center; Slovakia: EC VOU, Východoslovenského onkologického ústavu, EC VOU, Východoslovenského onkologického ústavu, a.s.; Slovenia: National Medical Ethics Committee of Republic Slovenia; Belgium: Ethics Committee of the Institut Jules Bordet; Macedonia: Macedonian Agency for Medicines and Medical Devices; Bosnia and Herzegovina: Ethics Committee of University Clinical Centre Sarajevo, Ethics Board of the University Clinical Centre of the Republic of Srpska; Croatia: The Agency for Medicinal Products and Medical Devices).
: All subjects provided written informed consent before the initiation of study procedures.
: Not applicable.
: The data that support the findings of this study are available from the corresponding author upon reasonable request.
: Not applicable.
: All authors were involved in the study conception and design and/or analysis and interpretation of the data, drafting the paper and/or revising it critically for intellectual content, approved the final version to be published, and agree to be accountable for all aspects of the work.
