drugset / Trial / NCT05072106
Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bosentan | Other / unclassified | 125 mg | Oral |
| Comparator | Lurbinectedin | Other / unclassified | 3.2 mg/m2 | Intravenous |