Phase 1
Completed N=20
A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors
Advanced Solid Neoplasm
Source: ClinicalTrials.gov NCT03486314 ↗
Enrolled (actual)
20
Serious AEs
27.0%
Results posted
Apr 2022
Primary outcomePrimary: Part A: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) — 0.962 ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Ratio of Maximum Observed Plasma Concentration (Cmax) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) |
0.962 | — |
| PRIMARY Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) |
0.785 | — |
| PRIMARY Part A: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) |
0.790 | — |
| SECONDARY Part A: Total Clearance After Intravenous Administration (CL) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) |
35.22; 43.77 | — |
| SECONDARY Part A: Volume of Distribution at Steady State After Intravenous Administration (Vss) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) |
312.82; 296.10 | — |
| SECONDARY Part A: Terminal Disposition Phase Half-life (T1/2z) for Pevonedistat Without Rifampin (Day 1) and With Rifampin (Day 10) |
7.442; 5.708 | — |
| SECONDARY Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment |
0; 0; 2; 1; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants who have a histologically or cytologically confirmed metastatic or locally advanced solid tumor that is appropriate for treatment with either docetaxel or carboplatin + paclitaxel in Part B of this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Expected survival of at least 3 months from the date of enrollment in the study.
- Recovered (that is, less than or equal to ( =) 25% of the hematopoietically active bone marrow.
- Life-threatening illness or serious (acute or chronic) medical or psychiatric illness unrelated to cancer.
- Active, uncontrolled infection or severe infectious disease.
- Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or hepatitis C infection.
- With significant heart or pulmonary disease.
- Requiring chronic treatment with breast cancer resistance protein (BCRP) inhibitors.
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.
Data sourced from ClinicalTrials.gov (NCT03486314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.