RecruitingPHASE3INTERVENTIONAL

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

This study is testing a new combination of treatments, called avutometinib and defactinib, for women with a type of ovarian cancer called low-grade serous ovarian cancer (LGSOC). This cancer has come back after previous treatment with platinum-based therapy. The study aims to find out if this new drug combination is safe and works better than existing standard treatments. These standard treatments include pegylated liposomal doxorubicin, paclitaxel, letrozole, and anastrozole. Researchers will look at how long people live without their cancer growing (progression-free survival), overall survival, safety, and how the treatments affect their quality of life. This is a Phase 3 study, meaning it's in the final stages of testing before a treatment might be made widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Verastem, Inc.

Enrolment target

270

Start

18 Mar 2024

Estimated completion

09 Feb 2031

Low Grade Serous Ovarian Cancer

What is this study about?

This important study is designed for women living with low-grade serous ovarian cancer (LGSOC) that has returned after an earlier round of treatment. When cancer comes back, it's called 'recurrent'. In this study, doctors are particularly interested in LGSOC that has progressed after a 'platinum-based' chemotherapy, which is a common type of cancer treatment.

The main goal is to compare a new experimental combination of drugs, called avutometinib and defactinib, against standard treatments currently used for LGSOC. Avutometinib and defactinib are special types of medicines known as 'kinase inhibitors'. These drugs work by blocking specific signals within cancer cells, which can help stop them from growing. Researchers want to see if this new combination is more effective at stopping cancer growth and improving how long patients live, while also checking if it's safe and doesn't cause too many side effects.

By taking part, you would be helping medical science learn more about the best ways to treat LGSOC. The study will closely monitor your health, your cancer progression, and how you feel generally, including your quality of life. This research is crucial because it could lead to new and better treatment options for women with this specific type of ovarian cancer in the future.

Key takeaways

This study evaluates a new drug combination for recurrent low-grade serous ovarian cancer.
It compares the new treatment to standard care to see which is safer and more effective.
The new drugs, avutometinib and defactinib, are called 'kinase inhibitors' and block cancer growth.
Participation involves regular clinic visits, tests, and monitoring.
You have the right to withdraw from the study at any time.
This research hopes to find better treatments for this specific type of ovarian cancer.

Who may be eligible?

To join this study, you would need to be a woman, aged 18 or older, who has been diagnosed with low-grade serous ovarian cancer. Your cancer must have returned or gotten worse after you've already had at least one other treatment for it that included a platinum-based medicine. The doctors will also need to be able to measure your cancer on scans and check if it has a specific gene change called a KRAS mutation.

There are also some health requirements. You'll need to be well enough to go about your daily activities (doctors call this a good 'performance status'), and your organs, like your liver and kidneys, need to be working properly. If you've recently had other treatments, you'd need to have recovered from any side effects before starting the study drugs. You also need to be suitable for at least one of the standard treatments used in this study.

Some things would mean you couldn't take part. For example, if you've recently had major surgery, other specific cancer treatments, or certain active health problems like a severe skin disorder or uncontrolled brain tumours. Also, if you've already been treated with avutometinib or defactinib, or similar drugs, you would not be eligible 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 a woman aged 18 or over with low-grade serous ovarian cancer?
Has your cancer returned or progressed after platinum-based chemotherapy?
Are you generally well and able to carry out daily activities?
Have you fully recovered from side effects of previous treatments?
Are you not currently pregnant or planning to become so during the study?
Have you NOT previously taken avutometinib or defactinib?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will first go through a screening process to make sure it's suitable for you. Once you're in the study, you'll be assigned by chance (like flipping a coin) to receive either the new combination of avutometinib plus defactinib, or one of the standard approved treatments for your condition. This is called 'randomisation'.

Throughout the study, you will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how your cancer is responding. The doctors will also ask you about your quality of life and any symptoms you might be experiencing. These visits will continue for as long as your treatment is working or until you or your doctor decide to stop the study treatment. Afterwards, there will be follow-up appointments to check on your long-term health. If you are on a standard treatment and your cancer gets worse, you might have the option to switch over to receive the new avutometinib and defactinib combination. The total duration of your participation will depend on how you respond to treatment and your individual situation.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new experimental treatment that isn't widely available yet, which could be more effective than current standard options. Your health will also be closely monitored by a team of specialists. However, like all medicines, the study drugs can have side effects, and it's possible that the new combination may not work better than existing treatments, or it might cause unexpected side effects. Researchers will carefully explain and monitor any potential risks. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (106)

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

HonorHealth
Verified postcode
Phoenix, United States· Recruiting
University of Arkansas
Verified postcode
Little Rock, United States· Recruiting
UCLA Health
Verified postcode
Los Angeles, United States· Recruiting
UC Davis
Verified postcode
Sacramento, United States· Recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
Yale University
Verified postcode
New Haven, United States· Recruiting
Florida Cancer Specialists - South
Verified postcode
Fort Myers, United States· Recruiting
Mount Sinai
Verified postcode
Miami Beach, United States· Recruiting
AdventHealth
Verified postcode
Orlando, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Florida Cancer Specialists Research East
Verified postcode
West Palm Beach, United States· Recruiting
Winship Cancer Institute at Emory University
Verified postcode
Atlanta, United States· Recruiting

Common questions

What is low-grade serous ovarian cancer?

It's a less common type of ovarian cancer that tends to grow more slowly than other types. This study focuses on when it comes back after initial treatment.

What are 'kinase inhibitors'?

These are drugs that block specific signals inside cancer cells, which helps to stop them from growing and spreading.

Why is this called a 'Phase 3' study?

Phase 3 means it's one of the final stages of testing. The drugs have already shown some promise in earlier studies, and now they're being compared to existing treatments in a larger group of patients.

What does 'recurrent' mean?

It means the cancer has come back after it was treated before. This study is for ovarian cancer that has returned.

Can I choose which treatment I get in the study?

No, you would be randomly assigned to either the new drug combination or one of the standard treatments, like drawing lots. This helps make the study fair and scientific.

How to find out more

Verastem Call Center

ramp301trialsupport@verastem.com 781-292-4204 Official trial record

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