drugset / Trial / NCT05101265
Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Lurbinectedin is mainly eliminated by the liver. Thus, Hepatic Impairment (HI) may alter the plasma concentrations of lurbinectedin. This study is designed to examine the PK and safety of an adjusted dose of lurbinectedin when administered to patients with HI. The results of this study may be used to support future clinical studies in patients and prescribing information in future labeling.
Timeline
- Start
- 2021-03-09
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lurbinectedin | Other / unclassified | 1.6 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 3.2 mg/m2 | Intravenous |