Phase 2 N=39 Other

Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors

Solid Tumors

Bottom Line

View on ClinicalTrials.gov: NCT02451007 ↗

Enrolled (actual)

Serious AEs

23.1%

Results posted

Feb 2019

Primary outcome: Primary: Change in QTcF (QT Corrected According to Fridericia's Formula) — 3.32; 1.76; 1.84; 1.32 ms (Milliseconds)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: lurbinectedin (PM01183) (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: PharmaMar
Primary completion: Aug 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

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.