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NCT03330106 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT03330106: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT03330106 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03330106, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study 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).
Primary Outcome
Change from time-matched baseline in QTcF was assessed following a single intravenous dose administration of pevonedistat at 25 and 50 mg/m\^2 and was analysed by dose. Some participants were treated with pevonedistat 25 mg/m\^2 or 50 mg/m\^2 on Day 1 while others received treatment on Day 8. Data is reported at pre-dose and at multiple timepoints (1, 2, 3, 4, 6, 9, 11 and 24 hours) postdose up to Day 8 in Part A. Analysis of variance (ANOVA) was used for the analysis.
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Pevonedistat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2021-06-21 |
| Phase | Phase 1 |
What the finished NCT03330106 record still lists
NCT03330106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT03330106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03330106 about?
NCT03330106 is a clinical study titled "A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors". 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).
What is the current status of trial NCT03330106?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2017-11-15. Estimated completion is 2021-06-21.
What interventions are being tested in trial NCT03330106?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Paclitaxel (DRUG), Pevonedistat (DRUG).
Who is sponsoring clinical trial NCT03330106?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03330106's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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