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

PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

January 14, 2021

Primary Completion Date

January 18, 2022

Study Completion Date

January 18, 2022

Conditions
Advanced Solid Tumor
Interventions
DRUG

Lurbinectedin

3.2 mg/m² as a 1-hour i.v. infusion on Day 1.

DRUG

Bosentan

Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).

Trial Locations (2)

28040

Fundación Jiménez Diaz, Madrid

28050

Hospital de Sanchinarro, Madrid

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaMar

INDUSTRY