Pevonedistat
DrugPevonedistat intravenous infusion.
Other names: MLN4924; TAK-924
NCT Number: NCT03057366
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Magyar Honvédség Egészségügyi Központ Onkológiai osztály, Budapest, Hungary
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pevonedistat intravenous infusion.
Other names: MLN4924; TAK-924
[14C]-Pevonedistat intravenous infusion.
Docetaxel intravenous infusion.
Carboplatin intravenous infusion.
Paclitaxel intravenous infusion.
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Time frame: Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)
Time frame: Up to 168 hours post-dose
Time frame: Up to Cycle 11 (Cycle length =21 days)
The best overall response was defined as the participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD). It was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Millennium Pharmaceuticals, Inc.
Industry
A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]-Pevonedistat in Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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