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NCT02451007 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
A Phase 2 study, sponsored by PharmaMar.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT02451007: Completed Phase 2 study, sponsored by PharmaMar.
NCT02451007 is a Phase 2 study that has completed, run by PharmaMar. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02451007, a Phase 2 study, has completed, sponsored by PharmaMar.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in patients with selected solid tumors.
Primary Outcome
ΔQTCF (Change in QTcF); EOI (end of infusion); LSM (Least Square Means); PK (Pharmacokinetic(s)). On Day 1 (D1) of Cycle 1 (C1), LSM ΔQTcF should have low difference values, without any clear trend to change with time. Therefore, the upper bound (UB) of the (two-sided) 90%Confidence Interval (CI) at all time points had to be less than the protocol-specified cut-off of 20 ms at each time point. If so, non-inferiority of any ECG time point to baseline with respect of QTc prolongation could be co
Interventions
- DRUG lurbinectedin (PM01183)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2015-08-12 |
| Est. Completion | 2016-08-19 |
| Phase | Phase 2 |
What the finished NCT02451007 record still lists
NCT02451007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which lurbinectedin (PM01183) is the first listed.
NCT02451007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02451007 about?
NCT02451007 is a clinical study titled "Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors". Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in patients with selected solid ...
What is the current status of trial NCT02451007?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2015-08-12. Estimated completion is 2016-08-19.
What interventions are being tested in trial NCT02451007?
The interventions under investigation include: lurbinectedin (PM01183) (DRUG).
Who is sponsoring clinical trial NCT02451007?
This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02451007's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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