Study of Lurbinectedin and Irinotecan for Patients with Advanced Solid Tumors

1 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of a combination of two medications, lurbinectedin and irinotecan, in patients who have been previously treated for certain types of advanced cancers known as solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The purpose of the study is to explore how well these medications work together in treating these tumors and to determine the best dose to use.

The study is divided into two phases. In the first phase, researchers aim to find the maximum dose of lurbinectedin that can be safely combined with irinotecan. In the second phase, the focus shifts to understanding how effective this combination is in fighting the cancer. Participants will receive the medications through an intravenous infusion, which means the drugs are delivered directly into the bloodstream through a vein. The study will monitor the participants’ response to the treatment and any side effects they may experience.

This trial is open-label, meaning both the researchers and participants know which treatment is being administered. It involves patients with various types of advanced solid tumors, including glioblastoma, soft-tissue sarcoma, endometrial carcinoma, epithelial ovarian carcinoma, mesothelioma, neuroendocrine tumors, small cell lung cancer, pancreatic adenocarcinoma, gastric carcinoma, and colorectal cancer. The study aims to provide valuable information on the potential benefits of using these medications together for treating these challenging conditions.

1 joining the study

Upon joining the study, the patient provides a signed and dated informed consent form. This is a document that confirms understanding of the study and agreement to participate.

The patient must have a confirmed diagnosis of advanced disease in specific tumor types, such as glioblastoma or soft-tissue sarcoma, among others.

2 initial assessment

An initial assessment is conducted to ensure the patient meets all eligibility criteria. This includes adequate bone marrow, liver, and kidney function, as well as a life expectancy of at least three months.

The patient must have recovered from any side effects of previous treatments to a certain level, except for hair loss, skin issues, nerve damage, or fatigue.

3 treatment phase I

In the phase I escalation stage, the patient receives a combination of lurbinectedin and irinotecan through intravenous administration. The goal is to determine the maximum tolerated dose and the recommended dose.

The treatment involves a powder that is mixed into a solution for infusion. The specific dosage and frequency are adjusted based on the patient’s response and tolerance.

4 treatment phase II

In the phase II expansion stage, the patient continues to receive the combination of lurbinectedin and irinotecan at the recommended dose determined in phase I.

The focus is on evaluating the effectiveness of the treatment in reducing tumor size or slowing its growth.

5 monitoring and follow-up

Throughout the study, the patient undergoes regular monitoring to assess safety, side effects, and the body’s response to the treatment.

This includes blood tests, imaging studies, and other evaluations as needed to track the progress of the disease and the impact of the treatment.

6 completion of the study

The study is estimated to conclude by January 2026. Upon completion, the patient’s overall response to the treatment is evaluated.

The results contribute to understanding the potential benefits and risks of the treatment combination for future patients with similar conditions.

Who Can Join the Study?

You must sign a written consent form before any study procedures begin.
If you are in the Phase II part of the study, your tumor must be measurable according to specific criteria. For glioblastoma patients, additional criteria apply.
You need to wait at least 3 weeks after your last cancer treatment before joining the study. This includes treatments like immunotherapy and radiotherapy. For certain drugs, the wait might be longer. Glioblastoma patients have specific waiting periods.
Your body must be functioning well enough, which includes:
- Having enough platelets, a type of blood cell that helps with clotting.
- Having enough hemoglobin, which carries oxygen in your blood.
- Having enough neutrophils, a type of white blood cell that fights infection.
- Having liver enzymes (AST and ALT) within acceptable levels, even if you have liver metastases.
- Having alkaline phosphatase (ALP) within acceptable levels, especially if you have liver metastases.
- Having bilirubin levels within acceptable limits, which indicates liver function.
- Having an INR below 1.5, unless you are on blood thinners.
- Having a creatinine clearance of at least 30 mL/minute, which shows kidney function.
- Having creatine phosphokinase (CPK) within acceptable levels.
- Having albumin levels of at least 3.0 g/dL, which is a protein in your blood.
You must have recovered from any side effects of previous treatments to a certain level, except for hair loss, skin issues, nerve damage, or fatigue.
You must be at least 18 years old.
Your performance status, which measures your ability to carry out daily activities, must be 1 or less on the ECOG scale.
You must have a life expectancy of at least 3 months.
You must have a confirmed diagnosis of advanced disease in specific types of tumors, such as glioblastoma, soft-tissue sarcoma, endometrial carcinoma, and others.
The number of previous treatments you have had is limited, depending on the phase of the study and the type of cancer you have.

Who Cannot Join the Study?

Patients who have not been diagnosed with selected advanced solid tumors cannot participate. Advanced solid tumors are types of cancer that form solid masses and have progressed to a more serious stage.
Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups.
Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who have any other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Cetbqh Lqxs Bmuwaz	Lyon	France
Hyrqxtcj Udpqyzsumsdya Muxlxkh Dz Vpsopgtogm	Santander	Spain
Htiondws Dq Lp Ssutm Cyoh I Sxuq Pdz	Barcelona	Spain
Fsogmywmp Pukz Lc Itpcpqzvfvohv Bnylqdotc Dmg Hqlnumbj Uxhxwvqsuqgdu Ls Pjk	Madrid	Spain
Hpgpqorl Vcgf didfgqvc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.03.2016
Italy	Not recruiting	01.03.2016
Spain	Not recruiting	01.03.2016

Trial locations

Investigated drugs:

Lurbinectedin is a medication being studied for its potential to treat certain advanced solid tumors. It works by interfering with the DNA of cancer cells, which may help to stop their growth and spread. In this trial, it is being tested in combination with another drug to determine the best dose and to see how effective it is in treating these types of cancers.

Irinotecan is a chemotherapy drug that is used to treat various types of cancer. It works by inhibiting an enzyme that cancer cells need to divide and grow. In this clinical trial, irinotecan is combined with lurbinectedin to explore whether the combination is more effective in treating advanced solid tumors than using the drugs separately.

Investigated diseases:

Neoplasm malignant

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body. The progression of these tumors can lead to a range of symptoms depending on their location and size. They are often characterized by their ability to resist standard treatments and may require more aggressive therapeutic approaches. Understanding the behavior and progression of these tumors is crucial for developing effective treatment strategies.

Trial ID:

2024-515394-10-00

Protocol code:

PM1183-A-014-15

NCT ID:

NCT02611024

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Lurbinectedin and Irinotecan for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?