AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Phase I/II randomized clinical trial of selinexor plus gemcitabine in selected advanced soft-tissue sarcomas

This study is for people with advanced soft-tissue sarcoma, specifically leiomyosarcoma or malignant peripheral nerve sheath tumour. It's a two-part study (Phase I and Phase II) that combines a new drug called selinexor with a common cancer treatment, gemcitabine. The first part (Phase I) focuses on finding the safest dose of selinexor and understanding its side effects when given with gemcitabine. The second part (Phase II) will then look at whether this combination treatment can help keep the cancer from growing or spreading for at least six months. Researchers will also be checking how long people live, how much the tumours shrink, and people's general well-being during the study.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Asociacion Europea Y Latinoamericana SELNET Para La Investigacion En Sarcomas

Enrolment target

Start

27 Dec 2024

Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.

What is this study about?

This research study is looking for better ways to treat advanced soft-tissue sarcomas. These are rare types of cancer that start in the body's soft tissues, like muscle or fat. The specific types of soft-tissue sarcoma included in this study are leiomyosarcoma and malignant peripheral nerve sheath tumour. When we say 'advanced,' it means the cancer has spread or cannot be removed by surgery.

The study combines two medications: selinexor and gemcitabine. Gemcitabine is a chemotherapy drug already used to treat certain cancers, while selinexor is a newer medicine. The main idea is to see if using these two drugs together might be more effective than current treatments for people with these specific advanced sarcomas.

This study has two main steps. The first step (Phase I) is about trying to find the safest dose of selinexor when it’s given with gemcitabine. The researchers will carefully watch for any side effects. Once a safe dose is found, the second step (Phase II) will then check how well this combined treatment works. They will particularly be looking to see if it can stop the cancer from growing or spreading for at least six months and how it affects people's overall health and quality of life.

Key takeaways

This study is testing a new drug combination for specific advanced soft-tissue sarcomas.
It aims to find a safe dose and see how well it controls cancer growth.
The study involves regular visits, tests, and careful monitoring for side effects.
Both men and women aged 18 and over can participate if they meet certain criteria.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. Both men and women can take part.

You must have been diagnosed with an advanced soft-tissue sarcoma. Specifically, the study is for two types: leiomyosarcoma or malignant peripheral nerve sheath tumour. 'Advanced' means the cancer has spread or is difficult to treat with standard methods.

There might be other health checks or specific requirements your doctor would need to assess to make sure this study is right and safe for you. It's important to discuss your full medical history with your care team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced leiomyosarcoma or malignant peripheral nerve sheath tumour?
Have you discussed your cancer treatment history with your doctor?
Are you able to attend regular hospital visits and appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the new combination treatment, selinexor plus gemcitabine. The specific schedule and dose for selinexor would be determined in the first part of the study, while gemcitabine is usually given as an infusion.

You would have regular visits to the hospital for treatment, check-ups, and tests. These tests include blood tests, physical examinations, and scans (like CT or MRI scans) to see how the tumour is responding. You would also be asked to answer questionnaires about your quality of life. The study team would carefully monitor you for any side effects throughout your time on the trial. The total duration of your participation would depend on how your cancer responds to the treatment and your overall health, but you would be followed for at least six months to assess the treatment's effects.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from a new treatment that isn't widely available yet, which could help control your cancer. However, there's no guarantee the treatment will work for everyone, and it might not be better than existing treatments. Like all medicines, selinexor and gemcitabine can cause side effects, which the study team will monitor closely. You will be told about all known potential risks before you decide to join. Remember, taking part in a study is always voluntary, and you can change your mind and withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a soft-tissue sarcoma?

Soft-tissue sarcomas are rare types of cancer that form in the body's soft tissues, like muscles, fat, blood vessels, or nerves. This study looks at two specific types.

What does 'advanced' cancer mean in this study?

In this study, 'advanced' means the cancer has either spread to other parts of the body or cannot be completely removed by surgery.

What are selinexor and gemcitabine?

Gemcitabine is a common chemotherapy drug. Selinexor is a newer drug being tested to see if it can help fight cancer when combined with gemcitabine.

Will I know if the treatment is helping?

The study team will regularly perform scans and tests to monitor your tumour's response and will discuss the results with you.

How long would I be in the study?

The length of your participation depends on how you respond to the treatment and your health, but you would be followed for at least six months to see the effects.