A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)
This research study, called MAESTRA 2, is investigating a new treatment for advanced ovarian cancer. It's for women whose cancer has stopped responding to platinum-based chemotherapy and who have high levels of a specific protein called Cyclin E1. The study aims to compare a new drug, INCB123667, with standard chemotherapy treatments chosen by the patient's doctor. Researchers will look at how long patients live without their cancer getting worse, and also how long they live overall. They will also check if the cancer shrinks, how long any improvements last, and the overall quality of life for those taking part. This is a Phase 3 study, meaning it's a large trial to confirm if the new drug is effective and safe.
At a glance
What is this study about?
This study, called MAESTRA 2, is looking for better ways to treat a specific type of ovarian cancer. It focuses on women whose cancer has come back or spread even after they've had chemotherapy treatments that include platinum-based drugs. These types of cancers are sometimes called 'platinum-resistant'.
The researchers are particularly interested in patients whose cancer cells show high levels of a protein called Cyclin E1. They are comparing a new investigational drug, INCB123667, to some commonly used chemotherapy drugs for this type of ovarian cancer. The aim is to see if the new drug can help patients live longer without their cancer growing, and if it can extend their lives overall.
This is a 'Phase 3' study, which means it's a large, important step in testing new medicines. It's designed to confirm whether the new drug is both effective and safe when compared to current treatments. The study will also look at how patients feel during treatment, their general quality of life, and any side effects they might experience. This information helps doctors understand the full picture of how a new treatment might help patients.
Key takeaways
- This study evaluates a new drug for platinum-resistant ovarian cancer.
- It targets patients whose cancer has high levels of the Cyclin E1 protein.
- The new drug is compared to existing chemotherapy options.
- Participation involves regular checks and potentially new or standard treatment.
- The study aims to improve understanding and treatment for this specific cancer.
- It is a Phase 3 study, a critical stage in drug development.
Who may be eligible?
To be considered for this study, you must be a woman aged 18 or older. The study is specifically for women with ovarian cancer that has progressed, meaning it has grown or spread, despite previous treatment with platinum-based chemotherapy.
An important requirement is that your cancer cells must show high levels of a protein called Cyclin E1. The doctors leading the study will check for this specific protein in your cancer samples to see if you qualify. They will also review your health and medical history to make sure the study treatment is suitable for you.
There might be other detailed health requirements that your doctor will discuss with you to ensure your safety and that the study is right for your particular situation.
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 older?
- Do you have ovarian cancer that has grown or returned after platinum-based chemotherapy?
- Has your doctor confirmed your cancer has high levels of Cyclin E1 protein?
- Are you generally well enough to participate in a clinical trial?
What does participation involve?
If you decide to join this study, you might receive the new drug (INCB123667) or one of the standard chemotherapy drugs (Paclitaxel, Topotecan, Gemcitabine, or Caelyx). Which treatment you receive will be decided randomly, like flipping a coin. You won't get to choose which one you receive, and your doctor won't either.
You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors will carefully measure how your cancer responds and keep an eye on any side effects. You'll also be asked to complete questionnaires about how you're feeling and your quality of life during the study.
The study will involve taking the medication as prescribed and attending all scheduled visits. The total duration for your participation will depend on how you respond to the treatment, but monitoring for your health and progression will continue for some time.
Potential risks and benefits
Locations (8)
- —UnverifiedIreland
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedBelgium
Common questions
What is 'platinum-resistant ovarian cancer'?
This means your ovarian cancer has started to grow or spread again within a few months after being treated with chemotherapy drugs that contain platinum.
What is Cyclin E1?
Cyclin E1 is a protein found in cells. In this study, doctors are looking at patients whose cancer cells have unusually high levels of this protein.
What does 'randomized' mean in a study?
It means whether you get the new drug or standard chemotherapy will be decided by chance, like drawing lots. Neither you nor your doctor can choose.
Will I know if I'm getting the new drug or a standard treatment?
Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving.
What are the common chemotherapy drugs used in this study?
The study compares the new drug to standard options like Paclitaxel, Topotecan, Gemcitabine, or Caelyx (a type of Doxorubicin).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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