Not recruitingRare disease

Study of Eribulin for Adults with Advanced Solitary Fibrous Tumor in Second or Third Line Treatment

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Halaven, which contains the active substance eribulin. The study is specifically looking at its use in treating a type of cancer known as Advanced Solitary Fibrous Tumor. This is a rare type of tumor that can occur in various parts of the body and is often difficult to treat when it has progressed to an advanced stage.

The purpose of the study is to explore how effective eribulin is when used as a second or third treatment option for adults with this advanced tumor. Participants in the study will receive Halaven as an injection into a vein, which is known as an intravenous injection. The study will compare the effects of Halaven with those of a placebo, which is a substance with no active medication, to see how well the drug works in reducing the size of the tumor or slowing its growth.

Throughout the study, participants will receive regular injections and will be monitored for any changes in their condition. The study aims to gather information on the overall response of the tumor to the treatment, as well as other factors such as survival rates and any side effects experienced. The study is expected to continue until mid-2025, with the goal of providing valuable insights into the potential benefits of using eribulin for treating Advanced Solitary Fibrous Tumor.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will receive a detailed explanation of the trial, including its purpose and procedures.
The patient must provide written consent after understanding the information provided.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility, which includes checking organ function and cardiac health.
A pregnancy test is required for female patients of child-bearing potential.
Step 3
Treatment administration
The patient will receive eribulin as a solution for injection.
The medication, known as HALAVEN 0.44 mg/ml, is administered intravenously.
Step 4
Treatment cycle
The treatment is given in cycles, with each cycle lasting 21 days.
The patient will receive the medication on day 1 and day 8 of each cycle.
Step 5
Monitoring and evaluation
Throughout the trial, the patient's response to the treatment will be monitored using imaging techniques.
The effectiveness of the treatment will be evaluated based on tumor response and overall health.
Step 6
End of treatment
The treatment will continue until the patient experiences unacceptable side effects or the disease progresses.
The trial is expected to conclude by July 31, 2025.

Who can join the trial?

12 criteria

The patient or their legal representative must be able to read and understand the informed consent form and be willing to sign it before any study-related procedures.
The patient must have **adequate organ function**, meaning their organs are working well enough to participate in the study.
The patient must have a **cardiac ejection fraction** of 50% or higher, which is a measure of how well the heart is pumping blood, as checked by an echocardiogram (a heart ultrasound).
Female patients who can have children must have a negative pregnancy test within 7 days before starting each cycle of chemotherapy. Women who have gone through menopause must not have had a period for at least 12 months to be considered unable to have children. Both male and female patients who can have children must agree to use effective birth control during the study.
The patient must be at least 18 years old.
The patient must have a confirmed diagnosis of a **STAT6 positive solitary fibrous tumor**, which is a specific type of tumor, confirmed by examining a tumor sample.
The patient must have **locally advanced disease**, meaning the tumor cannot be completely removed by surgery, or the patient does not want surgery, or the tumor might be easier to remove after treatment, and/or the disease has spread to other parts of the body (metastatic disease).
The patient must have a disease that can be measured or evaluated using **RECIST 1.1**, which is a standard way to measure how tumors respond to treatment.
The patient must show evidence of disease progression, meaning the disease has gotten worse, according to RECIST 1.1, within 6 months before joining the study.
The patient must have had at least one previous treatment for the advanced phase of the disease, with a maximum of two treatments. These treatments could be chemotherapy or targeted therapy.
The patient must have an **ECOG Performance Status** of 2 or less, which is a scale that measures how well a patient can perform daily activities.
The patient must have **adequate bone marrow function**, meaning their bone marrow is working well enough to participate in the study.

Who cannot join the trial?

4 criteria

Patients who have a different type of tumor than the one being studied.
Patients who are not in the 2nd or 3rd line of treatment for their condition. This means they have not tried one or two other treatments before.
Patients who are not adults. This study is only for adults.
Patients who are part of a vulnerable population. This means people who might need extra protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
Verified
Universita' Campus Bio-medico Di Roma
Rome, Italy

Trial locations

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Investigated drugs

Eribulin is a medication being studied for its effectiveness in treating advanced Solitary Fibrous Tumor in adult patients. It is used in this trial as a second or third line of treatment, meaning it is given to patients who have already tried other treatments. Eribulin works by interfering with the growth of cancer cells, which may help to slow down or stop the progression of the tumor.

Eribulin

What is already known about the treatment

Eribulin – Eribulin is administered as an intravenous injection, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating advanced solitary fibrous tumors, particularly as a second or third-line treatment option. The main therapeutic indication for eribulin in this context is to manage and potentially reduce the progression of these tumors. At the molecular level, eribulin works by inhibiting the growth of cancer cells through the disruption of microtubule dynamics, which are essential for cell division. It is classified pharmacologically as a microtubule inhibitor, a type of chemotherapy agent.

Investigated diseases

Advanced Solitary Fibrous Tumor – This is a rare type of tumor that originates in the connective tissue, often found in the lining of the lungs or other areas of the body. It is characterized by its slow growth, but in advanced stages, it can become more aggressive and spread to other parts of the body. The tumor is typically solitary, meaning it appears as a single mass, and can vary in size. As it progresses, it may cause symptoms depending on its location, such as pain or pressure on nearby organs. The exact cause of solitary fibrous tumors is not well understood, and they can occur in individuals of any age, though they are more common in adults.