Phase 2
Completed N=39
Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Source: ClinicalTrials.gov NCT02451007 ↗Enrolled (actual)
39
Serious AEs
23.1%
Results posted
Feb 2019
Primary outcomePrimary: Change in QTcF (QT Corrected According to Fridericia's Formula) — 3.32; 1.76; 1.84; 1.32 ms (Milliseconds)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in QTcF (QT Corrected According to Fridericia's Formula) |
3.32; 1.76; 1.84; 1.32; -8.24; -12.4 | — |
| SECONDARY Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Plasma Concentration) |
2.06 | — |
| SECONDARY Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Predicted ΔQTcF) |
2.94 | — |
| SECONDARY Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Intercept) |
-6.40 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02451007). 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.