drugset / Trial / NCT05072106

Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors

NCT05072106

Phase 1 Completed 11 enrolled PharmaMar
RandomizedCrossoverOpen-labelTreatment

Summary

Prospective, open-label, two-way crossover, phase Ib drug-drug interaction study in patients with advanced solid tumors. The study consisting of two lurbinectedin cycles, one cycle in combination with bosentan and one cycle as single agent (in different order depending on the study sequence), and one additional third cycle of lurbinectedin as a single agent for patients who meet the continuation criteria and obtain a clinical benefit after the first two cycles.

Timeline

Start
2021-01-14
Primary completion
2022-01-18
Completion
2022-01-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bosentan Other / unclassified 125 mg Oral
Comparator Lurbinectedin Other / unclassified 3.2 mg/m2 Intravenous

Indications