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

Millennium Pharmaceuticals, Inc.8 enrolled

Overview

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.

The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people with advanced solid tumors. The study will enroll approximately 4 to 6 pharmacokinetics (PK)-evaluable participants in part A. After completion of the mass balance and absorption, distribution, metabolism, excretion (ADME) assessment in Part A of the study, eligible participants will have the opportunity to continue into Part B at a secondary study site, which would begin in approximately 2 weeks of completion of Part A. * \[14C\]-Pevonedistat 25 mg/m\^2 * Part B (optional): Pevonedistat in combination with chemotherapy regimens (Pevonedistat 25 mg/m\^2 + docetaxel 75 mg/m\^2 or pevonedistat 20 mg/m\^2 + carboplatin 20 mg/m\^2 + paclitaxel 175 mg/m\^2) All participants will receive study drug via intravenous route. This multi-center trial will be conducted in Hungary. Participants will remain confined to the study site for 9 to 14 days in Part A. Participation in Part B is optional, participants will be re-evaluated for inclusion/exclusion criteria before administrating treatment. Participants will undergo treatment in Part B for a maximum of 12 cycles (21 days cycle each) and will include approximately 36 weeks for Part A and B combined. Participants will attend an end of study visit 30 days after the last dose of study drug in both Part A and B.

Study Type

INTERVENTIONAL

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors, Neoplasms, Advanced Solid

Interventions

PevonedistatDRUG

Pevonedistat intravenous infusion.

[14C]-PevonedistatDRUG

\[14C\]-Pevonedistat intravenous infusion.

DocetaxelDRUG

Docetaxel intravenous infusion.

Carboplatin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is felt to be appropriate for treatment with one of the 2 chemotherapy regimens in Part B of this study (carboplatin+paclitaxel or docetaxel), or have progressed despite prior standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurable. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 3. Expected survival longer than 3 months from enrollment in the study. 4. Recovered (that is, less than or equal to \[\<=\] Grade 1 toxicity) from the effects of prior antineoplastic therapy. Exclusion Criteria: 1. Has irregular defecation patterns (less than 1 defecation per 2 days or excessive diarrhea) and/or has a history of changes in bowel habits with daily routine or environment changes. 2. Prior treatment with radiation therapy involving greater than or equal to (\>=) 25% of the hematopoietically active bone marrow.

Locations (2)

Magyar Honvédség Egészségügyi Központ Onkológiai osztály

Budapest, Hungary

PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely

Budapest, Hungary