Ongoing, recruitingPhase I and Phase II (Integrated)- Bioequivalence StudyInterventional

Phase I/II randomized trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcomas

This clinical trial is designed for adult patients who have advanced soft tissue sarcoma, a type of cancer that starts in soft tissues like muscle or fat. The main goal of the study is to find out if adding a drug called LB-100 to the usual treatment (doxorubicin) is more effective and safe than doxorubicin by itself. Researchers will be looking at how long people live without their cancer getting worse (progression-free survival) and checking for any side effects. The study is split into two parts: an early phase to find the right dose of LB-100 when given with doxorubicin, and a later phase to see how well this combination works against specific types of sarcoma, such as undifferentiated pleomorphic sarcoma or leiomyosarcoma.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Bioequivalence Study

Sponsor

Asoc Grupo Espanol De Investigacion En Sarcomas

Enrolment target

157

Start

14 May 2024

Phase I:Adult patients with centrally confirmed diagnosis of advanced/metastatic undifferentiated pleomorphic sarcoma leiomyosarcoma myxoid/and hypercellular myxoid liposarcoma myxofibrosarcoma NOS sarcoma synovial sarcoma fibrosarcoma malignant peripheral nerve sheath tumor epitheloid sarcoma pleomorphic rhabdomyosarcoma pleomorphic liposarcoma and angiosarcoma

What is this study about?

This study is for adults who have a type of cancer called advanced soft tissue sarcoma. This means the cancer has grown or spread in the body. Soft tissue sarcomas are rare cancers that can affect various parts of the body, and they are named after the tissues they start in, such as muscle, fat, nerves, or blood vessels.

The main purpose of this research is to test a new treatment approach. We want to see if adding a new drug, called LB-100, to a standard chemotherapy drug, doxorubicin, works better than doxorubicin on its own. Doxorubicin is a common treatment for these types of cancers. The study aims to understand how safe this new combination is and how effectively it can stop the cancer from growing or spreading. Researchers will be closely monitoring participants to see how their cancer responds to the treatment and to identify any side effects.

The study has two main steps. The first step involves a small group of patients, and its goal is to find the safest and most effective dose of LB-100 to use alongside doxorubicin. Once that dose is found, the second step will involve more patients with specific types of soft tissue sarcoma (undifferentiated pleomorphic sarcoma or leiomyosarcoma) to confirm the safety and effectiveness of the combined treatment. We hope this research will lead to better treatment options for people with advanced soft tissue sarcomas.

Key takeaways

This study is for adults with advanced soft tissue sarcoma.
It tests if adding a new drug (LB-100) to standard doxorubicin treatment works better.
The study has two stages: finding the right dose, then testing effectiveness in specific sarcoma types.
Participation involves regular clinic visits, checks, and scans.
You'll get close medical care, but there could be risks from the new drug.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. To be considered for the study, you must have been diagnosed by a specialist with a specific type of advanced soft tissue sarcoma.

In the first part of the study, a wider range of soft tissue sarcoma types are included, such as undifferentiated pleomorphic sarcoma, leiomyosarcoma, myxoid liposarcoma, synovial sarcoma, and several others. However, if your uterine sarcoma has specific genetic changes (BCOR or NTRK translocation), you would not be able to join.

For the second part of the study, the criteria are more specific. Only adult patients with advanced undifferentiated pleomorphic sarcoma or leiomyosarcoma are eligible. Your doctor will be able to confirm if your specific cancer type and stage fit the requirements for this study.

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 an adult aged 18 or older?
Have you been diagnosed with advanced soft tissue sarcoma?
If you have uterine sarcoma, have you been told it does NOT have BCOR or NTRK genetic changes?
Are you willing and able to attend regular clinic appointments and receive treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either doxorubicin alone or doxorubicin combined with the new drug LB-100. This will be decided by chance, like flipping a coin. You will receive these treatments on a regular schedule.

You will have several visits to the clinic for medical check-ups, blood tests, and scans (like X-rays or MRI) to see how you are responding to the treatment and to monitor for any side effects. These assessments will help the study doctors understand if the treatment is working and if it is safe for you.

The total length of time you will be involved in the study can vary. You will continue to receive treatment for as long as it is helping you and is safe, or until your cancer gets worse. Even after stopping the treatments, you will continue to have follow-up appointments to monitor your health and overall well-being. The study will also look at your quality of life using questionnaires.

Potential risks and benefits

Taking part in a clinical trial offers some potential benefits. You will receive close medical attention and access to a new experimental treatment (LB-100) that might be more effective than standard treatment alone. However, there are also potential risks. Any medication can cause side effects, and some of these might be serious. We don't yet know all the side effects of LB-100. You will be closely monitored for any unwanted effects throughout the study. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your future 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 soft tissue sarcoma?

Soft tissue sarcoma is a rare cancer that starts in the body's soft tissues, such as muscle, fat, nerves, blood vessels, or fibrous tissues.

What does 'advanced' or 'metastatic' mean?

This means the cancer has either grown significantly within the area it started or has spread to other parts of the body.

What is doxorubicin?

Doxorubicin is a common chemotherapy drug used to treat various types of cancer, including soft tissue sarcomas.

What does 'progression-free survival' mean?

This refers to the length of time a person lives without their cancer getting worse or spreading further.

Will I know if I'm getting the new drug or not?

In this type of study, participants are usually assigned to treatment groups randomly, and you might not know which specific treatment you are receiving until after the study is over.