At a glance
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A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]-Pevonedistat in Patients With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Pevonedistat, [14C]-Pevonedistat, and 3 other interventions for Advanced Solid Tumors, Neoplasms, Advanced Solid. Completed, enrolled 8 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Pevonedistat intravenous infusion.
\[14C\]-Pevonedistat intravenous infusion.
Docetaxel intravenous infusion.
Carboplatin intravenous infusion.
Paclitaxel intravenous infusion.