Phase 1
Completed N=44
A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors
Advanced Solid Neoplasm
Source: ClinicalTrials.gov NCT03330106 ↗
Enrolled (actual)
44
Serious AEs
32.9%
Results posted
Mar 2023
Primary outcomePrimary: Part A: Change From Time-matched Baseline in Fridericia-corrected QT Interval (QTcF) After Pevonedistat Administration — 1.310; -2.231; 3.180; -0.639 milliseconds
Summary
The purpose of this study is to characterize the effects of 25 and 50 milligram per square meter (mg/m^2) pevonedistat on the Fridericia corrected QT interval (QTcF) of the electrocardiogram (ECG).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Change From Time-matched Baseline in Fridericia-corrected QT Interval (QTcF) After Pevonedistat Administration |
1.310; -2.231; 3.180; -0.639; 0.840; -2.127 | — |
| SECONDARY Part A: Change From Time-matched Baseline in Individual Corrected QT Interval (QTcI) After Pevonedistat Administration |
2.099; -1.884; 3.580; -0.206; 1.477; -0.099 | — |
| SECONDARY Part A: Change From Time-matched Baseline in QRS After Pevonedistat Administration |
-0.459; -0.482; 1.447; 0.850; -0.212; -0.043 | — |
| SECONDARY Part A: Change From Time-matched Baseline in PR After Pevonedistat Administration |
-2.894; -1.220; 1.152; 3.360; -0.090; 1.514 | — |
| SECONDARY Part A: Change From Time-matched Baseline in Heart Rate (HR) After Pevonedistat Administration |
0.602; 0.981; -2.068; -1.595; -1.812; -0.556 | — |
| SECONDARY Part A: Cmax: Maximum Observed Plasma Concentration for Pevonedistat |
197; 509 | — |
| SECONDARY Part A: AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for Pevonedistat |
1190; 2510 | — |
| SECONDARY Part A: Terminal Phase Elimination Half-life (t1/2) for Pevonedistat |
7.21; 6.73 | — |
| SECONDARY Part B: Overall Response Rate (ORR) |
9.1; 8.3 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor(s) appropriate for treatment with one of the 2 combination therapies in Part B of this study, 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 longer than 3 months from enrollment in the study.
- Recovered (that is, grade less than or equal to [ =) 1500 per cubic millimeter (/mm^3).
- Platelet count >=100,000/mm^3.
- Laboratory values for hemoglobin, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and serum creatinine or calculated/measured creatinine clearance.
- Diarrhea symptoms resolved to Grade 1 or better.
- QTc interval <480 millisecond (msec).
- Computed tomography (CT) scan or magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis within 28 days of Cycle 1 Day 1.
Data sourced from ClinicalTrials.gov (NCT03330106). 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.