14
Participants
Start Date
October 7, 2020
Primary Completion Date
April 21, 2022
Study Completion Date
April 21, 2022
Lurbinectedin alone
The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
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.
Fundacion Jimenez Diaz, Madrid
Hospital HM Sanchinarro, Madrid
Lead Sponsor
PharmaMar
INDUSTRY