RecruitingPHASE3INTERVENTIONAL

Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)

This research study, called APROMISS, is testing a new medicine called AL3818 (anlotinib) for advanced soft tissue sarcomas. Specifically, it's currently focused on patients with alveolar soft part sarcoma (ASPS). The main goal is to find out if this new medicine is safe and if it can help shrink the cancer or stop it from growing. While the study originally looked at other types of sarcoma, it is now only recruiting people with ASPS. Participants with ASPS will receive the new medicine. The study aims to gather important information that could potentially lead to new treatment options in the future.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Advenchen Laboratories, LLC

Enrolment target

325

Start

15 Aug 2017

Estimated completion

01 Dec 2028

Alveolar Soft Part Sarcoma Leiomyosarcoma Synovial Sarcoma Soft-Tissue Sarcoma

What is this study about?

This study, known as APROMISS, is focused on exploring a new medicine called AL3818 (also known as anlotinib hydrochloride) for people living with certain types of advanced soft tissue sarcomas. Advanced means the cancer has either spread to other parts of the body or grown significantly.

The main purpose of this research is to see how well AL3818 works and how safe it is for patients. Currently, the study is only open to people with a specific type of cancer called alveolar soft part sarcoma (ASPS). It's important to know that while the study initially looked at other sarcomas, they are no longer accepting new patients for those specific conditions.

For those with ASPS, all participants will receive the study medicine, AL3818. Researchers will closely monitor how the medicine affects the cancer and check for any side effects. The information gathered from this study could help doctors understand if AL3818 could become a useful new treatment option for ASPS in the future.

Key takeaways

This study is testing a new medicine (AL3818) for advanced alveolar soft part sarcoma (ASPS).
It is currently only recruiting patients with ASPS, not other sarcoma types.
The main goals are to check the medicine's safety and effectiveness.
If you join, you will receive the new medicine and have regular check-ups.
There might be benefits, like a new treatment option, but also potential risks from the medicine.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you must first agree to take part by signing a consent form and fully understanding what the study involves. You need to be at least 18 years old.

Critically, the study is currently *only* accepting individuals who have been diagnosed with advanced alveolar soft part sarcoma (ASPS) that cannot be removed by surgery. You might be eligible whether or not you've had previous treatments for your ASPS.

Unfortunately, if you have leiomyosarcoma or synovial sarcoma, the study is no longer accepting new participants for those conditions. If you have any questions about whether this study is right for you, it's best to speak with your doctor.

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 at least 18 years old?
Do you have advanced alveolar soft part sarcoma (ASPS) that cannot be removed by surgery?
Are you willing to sign a consent form and understand the study requirements?
Are you available for regular hospital visits and check-ups?
Have you discussed this study with your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking the medicine AL3818, which is given as tablets. You'll take these tablets for 14 days, followed by 7 days off, in repeated cycles, as long as the medicine is helping you and you're not having difficult side effects. You'll have regular hospital visits for check-ups and tests to see how you're responding to the treatment and to monitor your health.

These visits will involve things like blood tests, scans (e.g., to check the size of your cancer), and physical examinations. The doctors will closely watch for any changes in your health. The total time you'll be on the study will depend on how you respond to the treatment, but it will continue as long as the treatment is working and you are tolerating it well.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new medicine that is not yet widely available for your condition. It might help to shrink your cancer or slow its growth. However, there's no guarantee the medicine will work, and all medicines have potential side effects. These could include mild issues or, in rarer cases, more serious problems. The study team will explain all known risks to you in detail. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (24)

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

Mayo Clinic Arizona
Verified postcode
Phoenix, United States· Completed
University of California Los Angeles
Verified postcode
Los Angeles, United States· Completed
Sarcoma Oncology Center
Verified postcode
Santa Monica, United States· Recruiting
Stanford Medicine Cancer Institute
Verified postcode
Stanford, United States· Completed
University of Colorado Denver
Verified postcode
Aurora, United States· Completed
Mayo Clinic Jacksonville
Verified postcode
Jacksonville, United States· Completed
University of Miami Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States· Completed
Northwestern University
Verified postcode
Chicago, United States· Completed
University of Michigan Comprehensive Cancer Center
Verified postcode
Ann Arbor, United States· Completed
Mayo Clinic Rochester
Verified postcode
Rochester, United States· Completed
Washington University St. Louis
Verified postcode
St Louis, United States· Completed
Columbia University Medical Center
Verified postcode
New York, United States· Withdrawn

Common questions

What is AL3818?

AL3818 is a new medicine being tested in this study to see how well it works for advanced alveolar soft part sarcoma.

Which type of cancer is this study for?

Currently, this study is only for people with advanced alveolar soft part sarcoma (ASPS).

Will I definitely receive the new medicine?

Yes, if you have ASPS and join this study, you will receive the study medicine, AL3818.

How often will I take the medicine?

You'll take the tablets for 14 days, then have 7 days off, repeating this cycle.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Shiying Clinical Trial Manager

shiyings@advenchen.com 8055301550 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.