Pevonedistat
DrugPevonedistat intravenous infusion.
Other names: MLN4924, TAK-924
NCT Number: NCT03486314
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Emory University, Atlanta, Georgia, United States
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:
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Criteria for Continuation into Optional Part B:
To be eligible for Part B, participants must have completed Part A and be reassessed to determine if they meet the continuation criteria for Part B.
Pevonedistat intravenous infusion.
Other names: MLN4924, TAK-924
Rifampin capsules.
Docetaxel intravenous infusion.
Carboplatin intravenous infusion.
Paclitaxel intravenous infusion.
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
The Least square (LS) means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
The LS means ratio of Day 10 over Day 1 were calculated from a mixed-model analysis of variance model.
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Time frame: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose
Time frame: Up to Cycle 17 (end of treatment) (Cycle length =21 days)
Best overall response was defined as participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD). It was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target and non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: at least 30 percent (%) decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameter. PD: at least 20% increase in sum of diameter of target lesions, taking as reference, smallest sum on study.
Millennium Pharmaceuticals, Inc.
Industry
A Phase 1 Study to Evaluate the Effects of Rifampin on Pharmacokinetics of Pevonedistat in Patients With Advanced Solid Tumors
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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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