A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors

Phase 1 Completed 20 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedSequentialOpen-labelOther

Summary

The purpose of this study is to assess the effect of multiple-dose administration of rifampin on the single dose PK of pevonedistat in adult participants with advanced solid tumors.

Timeline

Start: 2018-08-13
Primary completion: 2019-05-10
Completion: 2021-02-28

Publications

Zhou X, Vaishampayan U, Mahalingam D, Harvey RD, Chung KY, Sedarati F, Dong C, Faller DV, Venkatakrishnan K, Gupta N. Phase 1 study to evaluate the effects of rifampin on pharmacokinetics of pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):1042-1050. doi: 10.1007/s10637-022-01286-8. Epub 2022 Aug 6.

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
Subject	Rifampin	Small molecule	600 mg	Oral
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 Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications