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

NCT03057366 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-11-18

Study results available
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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.

Conditions

  • Advanced Solid Tumors, Neoplasms, Advanced Solid

Interventions

DRUG

Pevonedistat

Pevonedistat intravenous infusion.

DRUG

[14C]-Pevonedistat

\[14C\]-Pevonedistat intravenous infusion.

DRUG

Docetaxel

Docetaxel intravenous infusion.

DRUG

Carboplatin

Carboplatin intravenous infusion.

DRUG

Paclitaxel

Paclitaxel intravenous infusion.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Millennium Pharmaceuticals, Inc.

Study Design

Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-11
Primary Completion
2018-02-08
Completion
2018-11-05
FDA Drug
Yes

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03057366 on ClinicalTrials.gov