Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

May 6, 2016

Primary Completion Date

July 1, 2025

Study Completion Date

July 1, 2025

Conditions
Advanced Solid TumorsGlioblastomaSoft Tissue Sarcoma (Excluding GIST)Endometrial CarcinomaEpithelial Ovarian CarcinomaMesotheliomaGastroenteropancreatic Neuroendocrine TumorSCLCGastric CarcinomaPancreatic AdenocarcinomaColorectal CarcinomaNeuroendocrine Tumors
Interventions
DRUG

Lurbinectedin

lurbinectedin (PM01183) 4 mg vials

DRUG

Irinotecan

irinotecan 40 mg, 100 mg or 300 mg vials

Trial Locations (23)

10060

IRCCS Fondazione Candiolo (Turin), Torino

13125

Helios Klinikum Berlin Buch, Berlin

15526

Helios Kilinikum Bad Saarow, Bad Saarow

15706

Hospital Clínico Universitario de Santiago, Santiago de Compostela

28022

Hospital Universitario Puerta de Hierro, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Hospital Universitario Madrid Sanchinarro, Madrid

39008

Hospital Universitario Marqués de Valdecilla, Santander

41013

Hospital Virgen Del Rocio, Seville

50009

Hospital Universitario Miguel Servet, Zaragoza

69373

Centre Léon Bérard, Lyon

77030

The University of Texas MD Anderson Cancer Center, Houston

90403

Sarcoma Oncology Center, Santa Monica

94800

Institut Gustave Roussy, Villejuif

02114

Massachusetts General Hospital -, Boston

02215

Beth Israel Deaconess Medical Center, Boston

00128

Campus Biomedico, Roma

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Univeristari Vall d'Hebron, Barcelona

CH 3010

Inselspital Bern - Medizinische Onkologie, Bern

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaMar

INDUSTRY