NCT03486314

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

A Phase 1 Study to Evaluate the Effects of Rifampin on Pharmacokinetics of Pevonedistat in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will enroll approximately 20 participants. The study will be conducted in two Parts: Part A and optional Part B. Part A will have a drug-drug interaction (DDI) assessment. In Part A, participants will be assigned to: • Pevonedistat 50 mg/m\^2 + Rifampin Eligible participants from Part A will continue treatment in optional Part B with pevonedistat in combination with SoC chemotherapy, docetaxel or carboplatin plus paclitaxel. The investigator will decide which SoC combination partner a participant will receive. * Pevonedistat 25 mg/m\^2 + Docetaxel * Pevonedistat 20 mg/m\^2 + Carboplatin + Paclitaxel This multi-center trial will be conducted in the United States. The overall time to participate in this study is 18 months. Participants will make a final visit to the clinic 30 days after receiving their last dose of study drug or before the start of subsequent therapy.

Conditions

• Advanced Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Pevonedistat	Pevonedistat intravenous infusion.
DRUG	Rifampin	Rifampin capsules.
DRUG	Docetaxel	Docetaxel intravenous infusion.
DRUG	Carboplatin	Carboplatin intravenous infusion.
DRUG	Paclitaxel	Paclitaxel intravenous infusion.

Timeline

• Start date: 2018-08-13
• Primary completion: 2019-05-10
• Completion: 2021-02-28
• First posted: 2018-04-03
• Last updated: 2022-04-18
• Results posted: 2022-04-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study