A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors

Phase 1 Completed 68 enrolled Millennium Pharmaceuticals, Inc.

RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to characterize the effects of 25 and 50 milligram per square meter (mg/m\^2) pevonedistat on the Fridericia corrected QT interval (QTcF) of the electrocardiogram (ECG).

Timeline

Start: 2017-11-15
Primary completion: 2019-01-07
Completion: 2021-06-21

Publications

Zhou X, Richardson DL, Dowlati A, Goel S, Sahebjam S, Strauss J, Chawla S, Wang D, Mould DR, Samnotra V, Faller DV, Venkatakrishnan K, Gupta N. Effect of Pevonedistat, an Investigational NEDD8-Activating Enzyme Inhibitor, on the QTc Interval in Patients With Advanced Solid Tumors. Clin Pharmacol Drug Dev. 2023 Mar;12(3):257-266. doi: 10.1002/cpdd.1194. Epub 2022 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pevonedistat	Small molecule	20 mg/m2	Intravenous
Subject	Pevonedistat	Small molecule	25 mg/m2	Intravenous
Subject	Pevonedistat	Small molecule	50 mg/m2	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	175 mg/m2	Intravenous

A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications