drugset / Trial / NCT02451007

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

NCT02451007

Phase 2 Completed 39 enrolled PharmaMar
NaSingle-groupOpen-labelOther

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.

Timeline

Start
2015-08-12
Primary completion
2016-08-19
Completion
2016-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Lurbinectedin Other / unclassified 4 mg

Indications