Clinical trial · Interventional
Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients With Selected Solid Tumors
NCT02451007CI-TRIAL-00041748completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lurbinectedin (PM01183) | Drug | Lurbinectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A (lurbinectedin)
- description
- lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
- interventionNames
- Drug: lurbinectedin (PM01183)
Primary outcomes (1)
- measure
- Change in QTcF (QT Corrected According to Fridericia's Formula)
- timeFrame
- Scheduled post-baseline ECG time points were taken 5-10 min before their time-matched PK samples: i.e., 5 min before EOI, 30 min, 1, 3, 24, 72 and 168 hours after EOI of Cycle 1, and 5 min before EOI, 30 min, 1, 3 and 168 hours after EOI of Cycle 2.
- description
- 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 concluded
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntarily signed and dated informed consent * Normal cardiac conduction and function (centrally read) * Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic. * Specific serum electrolyte levels Exclusion Criteria: * Age \> 65 years * Performance status = 2 \[Eastern Cooperative Oncology Group (ECOG)\] * Heart rhythm disturbances * Significant ischemic coronary disease, heart failure, myocardial infarction, or unstable angina within the last six months. * Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) \> 450 mg/m²
References
Publications (0)
Data not yet available
No reference posted for this study.