Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
This study is investigating a new treatment for a type of cancer called leiomyosarcoma, specifically for patients whose cancer has come back or spread after previous treatment. Participants will receive either a new drug called ADI-PEG 20 or a placebo (a dummy drug), in addition to their standard chemotherapy (gemcitabine and docetaxel). Researchers want to see if adding ADI-PEG 20 is safe and helps slow down the cancer's growth or spread. This is a "Phase 3" study, meaning it's a larger trial aiming to confirm if the new treatment is better than existing options. It involves patients in different hospitals around the world and uses a blinded approach, so neither the patient nor their doctor will know if they are receiving the new drug or the placebo.
At a glance
What is this study about?
This study is focused on a type of cancer called leiomyosarcoma (LMS), which starts in smooth muscle cells and can appear in different parts of the body. It specifically looks at patients whose LMS has either spread or returned after they've already received some treatment, including a type of chemotherapy called an anthracycline.
The main goal is to compare a new medicine, ADI-PEG 20, with a dummy medicine (placebo). Both will be given alongside a standard chemotherapy combination of gemcitabine and docetaxel. Researchers want to find out if adding ADI-PEG 20 is a safe and effective way to help people with this advanced stage of LMS. This comparison will help determine if the new drug could become a valuable treatment option in the future.
This is a "Phase 3" clinical trial, which means it's a late-stage study involving a larger group of patients. The trial is designed to be "double-blind," meaning neither you nor your doctor will know if you're receiving ADI-PEG 20 or the placebo. This helps ensure the results are as unbiased as possible. The study is also taking place in many different medical centres globally, gathering a broad range of information to see how the treatment works across different people.
Key takeaways
- It's for people with advanced or spreading leiomyosarcoma (LMS).
- You must have already received some chemotherapy, including doxorubicin.
- It compares a new drug (ADI-PEG 20) with a dummy drug (placebo).
- Both are given with standard chemotherapy (gemcitabine and docetaxel).
- The study is investigating if the new drug is safe and effective.
- Neither you nor your doctor will know if you're getting the active drug or placebo.
Who may be eligible?
This study is for adults over 18 years old who have grade 2 or 3 leiomyosarcoma (LMS) that has been confirmed by a doctor. Your cancer should have either spread or come back after you've already had up to two types of chemotherapy for it, one of which must have included a specific drug called doxorubicin. The doctors need to be able to measure your cancer on scans to track its progress during the 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 18 years or older?
- Do you have a confirmed diagnosis of leiomyosarcoma (LMS)?
- Has your LMS been treated previously, including with doxorubicin?
- Can your cancer be measured on scans?
- Are your blood tests (like blood counts and liver/kidney function) within acceptable ranges?
- Are you willing to use effective contraception if needed?
What does participation involve?
If you join this study, as well as your standard chemotherapy (gemcitabine and docetaxel), you will receive either the investigational drug ADI-PEG 20 or a placebo (a dummy drug). This will be given through an injection. You'll need to attend regular appointments at the hospital for treatments, blood tests, physical examinations, and scans to check how you're responding and to monitor for any side effects. The study will involve several visits over a period, and you'll also have follow-up visits after your treatment finishes. The total duration of your participation, including follow-up, will depend on how your treatment progresses.
Potential risks and benefits
Locations (31)
- Mayo Clinic ArizonaVerified postcodePhoenix, United States· Recruiting
- USC Norris comprehensive cancer centerVerified postcodeLos Angeles, United States· Recruiting
- Stanford University Medical CentreVerified postcodePalo Alto, United States· Recruiting
- UCSFVerified postcodeSan Francisco, United States· Recruiting
- UCLAVerified postcodeSanta Monica, United States· Recruiting
- University of Colorado Cancer Center/ CU Anschutz Medical CampusVerified postcodeAurora, United States· Recruiting
- Mayo Clinic FloridaVerified postcodeJacksonville, United States· Recruiting
- University of Miami/ Sylvester Comprehensive Cancer CenterVerified postcodeMiami, United States· Recruiting
- Moffitt Cancer CenterVerified postcodeTampa, United States· Recruiting
- NorthwesternVerified postcodeChicago, United States· Recruiting
- Indiana UniversityVerified postcodeIndianapolis, United States· Recruiting
- University of IowaVerified postcodeIowa City, United States· Active not recruiting
Common questions
What is leiomyosarcoma (LMS)?
LMS is a rare type of cancer that starts in smooth muscle cells. These muscles are found in many parts of the body, like the uterus, stomach, bowel, and blood vessel walls.
What does 'previously treated' mean?
It means your cancer has already been treated with medicines like chemotherapy, and it has either returned or spread. For this study, you must have had at least one treatment containing doxorubicin.
What is a placebo?
A placebo is an inactive substance that looks exactly like the study drug but contains no active medicine. It helps researchers compare the effects of the active drug accurately.
Why is it called a 'double-blind' study?
Double-blind means that neither you nor your study doctor will know whether you are receiving the active study drug or the placebo. This helps prevent bias in the results.
Can I stop participating if I want to?
Yes, absolutely. Your participation is voluntary, and you can withdraw from the study at any time without having to give a reason. This won't affect your future medical care.
How to find out more
Mirla Langlois
Always speak to your GP or specialist before deciding to take part in a study.
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