Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

October 7, 2020

Primary Completion Date

April 21, 2022

Study Completion Date

April 21, 2022

Conditions
Advanced Solid Tumors
Interventions
DRUG

Lurbinectedin alone

The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.

DRUG

Lurbinectedin+Itraconazole co-administration

The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A.

Trial Locations (2)

28040

Fundacion Jimenez Diaz, Madrid

28050

Hospital HM Sanchinarro, Madrid

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaMar

INDUSTRY