A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors

Summary

The purpose of this study is to assess the mass balance (that is, cumulative excretion of total radioactivity \[TRA\] in urine and feces) and to characterize the pharmacokinetics (PK) of pevonedistat in whole blood, plasma, and urine, and of TRA in plasma and whole blood following a single 1-hour infusion of 25 milligram per square meter (mg/m\^2) \[14C\]-pevonedistat intravenous (IV) solution containing approximately 60 to 85 microcurie (mCi) (approximately 2.22-3.145 megabecquerel \[MBq\]) of TRA in participants with advanced solid tumors in Part A.

Timeline

Start

2017-05-11

Primary completion

2018-02-08

Completion

2018-11-05

Publications

• Zhou X, Sedarati F, Faller DV, Zhao D, Faessel HM, Chowdhury S, Bolleddula J, Li Y, Venkatakrishnan K, Papai Z. Phase I study assessing the mass balance, pharmacokinetics, and excretion of [14C]-pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors. Invest New Drugs. 2021 Apr;39(2):488-498. doi: 10.1007/s10637-020-01017-x. Epub 2020 Oct 22.

Drugs

Indications