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

Completed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors, Glioblastoma, Soft Tissue Sarcoma (Excluding GIST), Endometrial Carcinoma, Epithelial Ovarian Carcinoma, Mesothelioma, Gastroenteropancreatic Neuroendocrine Tumor, SCLC, Gastric Carcinoma, Pancreatic Adenocarcinoma, Colorectal Carcinoma, Neuroendocrine Tumors

In brief

Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage.

Key facts

Study ID

NCT02611024

Run by

PharmaMar

People needed

316

Starts

2016-05-06

Expected to finish

2025-07-01

Last updated by the study team

2025-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily signed and dated written informed consent prior to any specific-study procedure.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed diagnosis of advanced disease of any of the following tumor types:
• For the Lurbinectedin Escalation Group and the Irinotecan Escalation Group:
• Glioblastoma.
• Soft-tissue sarcoma (excluding gastrointestinal stromal tumors [GIST]).
• Endometrial carcinoma.
• Epithelial ovarian carcinoma (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas) regardless of platinum sensitivity.
• Mesothelioma.
• Gastroenteropancreatic neuroendocrine tumors (GEP-NET).
• Small cell lung cancer (SCLC).
• Pancreatic adenocarcinoma.
• Gastric carcinoma.
• Colorectal carcinoma (CRC).
• For the Intermediate Escalation Group:
• Endometrial carcinoma.
• SCLC.
• Other solid tumors may be included, if appropriate, after discussion between the Investigators and the Sponsor.
• For the Phase II expansion stage:
• Glioblastoma.
• Soft tissue sarcoma (including synovial sarcoma),
• Endometrial carcinoma.
• SCLC.

You may not qualify if…

• Concomitant diseases/conditions:
• History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within the previous year.
• Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
• Myopathy or any clinical situation that causes significant and persistent elevation of CPK (> 2.5 × ULN in two different determinations performed one week apart).
• Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C. Known Gilbert disease.
• Active uncontrolled infection.
• Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B.
• Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or sub-occlusion or paralysis.
• Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
• Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study
• Active Coronavirus disease (COVID-19).
• Hypersensitivity to any of the study drugs or their excipients.
• Prior treatment with lurbinectedin, trabectedin (Yondelis®) or topoisomerase I inhibitors (irinotecan, topotecan, etc.). Prior topoisomerase inhibitors (e.g., irinotecan) are only allowed in patients with colorectal carcinoma or NENs.
• Prior bone marrow or stem cell transplantation, or radiation therapy in more than 35% of bone marrow.
• Known brain metastases or leptomeningeal disease involvement. Glioblastoma lesions (primary or locally advanced) are eligible. Exception: patients with brain metastases are eligible provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment (patients taking steroids in the process of already being tapered within two weeks prior to screening are allowed). Brain CT-scan or MRI results must be provided at baseline.
• Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception. Women of childbearing potential (WOCBP) must agree to use an effective contraception method to avoid pregnancy during the course of the trial (and for at least six months after the last infusion). Fertile male patients must agree to refrain from fathering a child or donating sperm during the trial and for four months after the last infusion.
• Limitation of the patient's ability to comply with the treatment or follow-up protocol.

Where it is running

• Sarcoma Oncology Center — Santa Monica, California, United States
• Massachusetts General Hospital - — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Centre Léon Bérard — Lyon, France
• Institut Gustave Roussy — Villejuif, France
• Helios Kilinikum Bad Saarow — Bad Saarow, Germany
• Helios Klinikum Berlin Buch — Berlin, Germany
• Campus Biomedico — Roma, Italy
• IRCCS Fondazione Candiolo (Turin) — Torino, Italy
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Univeristari Vall d'Hebron — Barcelona, Spain
• Hospital Universitario Puerta de Hierro — Madrid, Spain
• Hospital Universitario Ramon y Cajal — Madrid, Spain
• Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Hospital Universitario La Paz — Madrid, Spain
• Hospital Universitario Madrid Sanchinarro — Madrid, Spain
• Hospital Universitario Marqués de Valdecilla — Santander, Spain
• Hospital Clínico Universitario de Santiago — Santiago de Compostela, Spain
• Hospital Virgen Del Rocio — Seville, Spain
• Hospital Universitario Miguel Servet — Zaragoza, Spain
• Inselspital Bern - Medizinische Onkologie — Bern, Switzerland

Full record on ClinicalTrials.gov

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