A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation
This research study is investigating new ways to treat a type of ovarian cancer called low-grade serous ovarian cancer (LGSOC) that has come back. We are looking at a drug called avutometinib, both on its own and in combination with another drug called defactinib. The main goals are to check how safe these treatments are, whether people can tolerate them well, and if they can help shrink the cancer or stop it from growing. This is a Phase 2 study, which means we're trying to get a better understanding of how well these new treatments work before they can be considered more broadly. We're hoping to find better options for people living with this condition.
At a glance
What is this study about?
This study is focused on a specific type of ovarian cancer called Low-Grade Serous Ovarian Cancer (LGSOC). Sometimes, after initial treatments, this cancer can return. Doctors are always looking for new and better ways to treat cancer, especially when it comes back. This research is testing one new drug, called avutometinib, and also seeing how it works when combined with another drug, called defactinib.
The main aim of this study is to see if these new treatments are safe and if they can help people whose LGSOC has returned. Researchers will be observing whether the treatments can stop the cancer from growing or even shrink it. By carefully studying patients who take part, doctors can learn valuable information that could help develop new treatment options in the future.
Taking part in a study like this helps doctors understand more about these new drugs and how they might work for people with LGSOC. It’s an important step in finding more effective and gentle ways to manage this type of cancer.
Key takeaways
- This study explores new treatments for a specific type of ovarian cancer that has returned.
- It tests two new drugs, avutometinib and defactinib, alone and in combination.
- The main goals are to check safety, tolerability, and how well the treatments work.
- Participation involves regular clinic visits, taking oral medication, and health monitoring.
- It's for women with low-grade serous ovarian cancer that has progressed after prior treatment.
- You can always choose to leave the study at any time.
Who may be eligible?
To join this study, you would need to have a confirmed diagnosis of low-grade serous ovarian cancer. Your cancer must have returned or progressed after you've already had at least one other treatment for it that spread to other parts of the body. Also, doctors need to be able to measure your cancer on scans.\n\nThere are other health checks too. You need to be generally well enough to take part, with important body functions (like your liver and kidneys) working properly. Any side effects from your previous treatments should have mostly cleared up. If you are able to become pregnant, you would need to agree to use effective contraception during the study.\n\nYou can't join if you've had certain treatments very recently, like other anti-cancer drugs or major surgery. You also can't have other types of ovarian cancer alongside the low-grade serous type. If you have serious heart or lung problems, or conditions like active skin issues or a history of specific muscle problems, you might not be able to participate. Also, recent severe COVID-19 symptoms or brain metastases requiring medication would prevent you from joining.
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.
- Is my ovarian cancer specifically low-grade serous?
- Has my cancer returned or progressed after at least one previous treatment?
- Am I generally well, with key body functions working well?
- Can doctors measure my cancer on scans?
- Am I able to take medications by mouth?
- Do I have any serious heart or lung conditions?
What does participation involve?
If you decide to take part in this study, you will likely have regular visits to the clinic for assessments. These visits will involve physical examinations, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. You will be taking the study medication by mouth, as advised by the study team. Some participants will receive avutometinib on its own, while others will receive avutometinib plus defactinib. The total duration of your participation will depend on how you respond to the treatment and your overall health, but there will be ongoing follow-up to check on your progress and well-being.
Potential risks and benefits
Locations (47)
- Arizona Oncology Associates PC HALVerified postcodeScottsdale, United States
- Sansum ClinicVerified postcodeSanta Barbara, United States
- Yale School of MedicineVerified postcodeNew Haven, United States
- Advent HealthVerified postcodeOrlando, United States
- H. Lee Moffitt Cancer Center and Research Institute - Center for Women's OncologyVerified postcodeTampa, United States
- University of ChicagoVerified postcodeChicago, United States
- Maryland Oncology and Hematology, P.A.Verified postcodeGlenn Dale, United States
- Minnesota Oncology Hematology PAVerified postcodeMinneapolis, United States
- Washington University School of MedicineVerified postcodeSt Louis, United States
- Comprehensive Cancer Centers of NevadaVerified postcodeLas Vegas, United States
- University of New Mexico Comprehensive Cancer CenterVerified postcodeAlbuquerque, United States
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States
Common questions
What is Low-Grade Serous Ovarian Cancer (LGSOC)?
LGSOC is a specific type of ovarian cancer that often grows more slowly than other types.
What are avutometinib and defactinib?
These are new experimental medications being tested to see if they can help treat LGSOC.
Why is this study only for people whose cancer has returned?
This study is designed for people whose LGSOC has come back after they've already had some treatment for it, as doctors are looking for new options in this situation.
What does 'Phase 2' study mean?
A Phase 2 study aims to further evaluate how safe a new treatment is and if it shows signs of working, usually in a larger group of people than earlier studies.
Will I have to pay to be in the study?
No, you will not have to pay for the study drugs or any of the study-related tests and procedures.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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