A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, vs Investigator's Choice Chemotherapy in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This research study is for women who have ovarian, primary peritoneal, or fallopian tube cancer that has come back or hasn't responded to platinum-based chemotherapy. Doctors are testing a new treatment called farletuzumab ecteribulin. This new drug is designed to target specific cancer cells. They will compare it to common chemotherapy medicines like Caelyx, paclitaxel, or topotecan. The main goals are to see how many women's tumours shrink or stop growing, and to understand any side effects that might lead people to stop the treatment. This is a Phase 2 study, meaning it's still an early stage of testing, focusing on whether the new drug works and is safe enough to be studied further.
At a glance
What is this study about?
This study is looking for better ways to treat certain types of cancer in women. Specifically, it's for ovarian, primary peritoneal, and fallopian tube cancer that is considered 'high-grade serous'. This means the cancer cells look very abnormal under a microscope. 'Platinum-resistant' means that usual chemotherapy drugs involving platinum (like carboplatin or cisplatin) are no longer working well to control the cancer.
The main idea behind this study is to test a new medicine called farletuzumab ecteribulin. This drug is special because it's designed to target specific markers often found on these cancer cells, like a key fitting into a lock. Once it finds these markers, it delivers a cancer-fighting medicine directly to the cancer cell. The researchers want to see if this new approach is more effective than standard treatments currently used when platinum-based chemotherapy stops working.
Participants in the study will be divided into groups. One group will receive farletuzumab ecteribulin, and another group will receive one of the standard chemotherapy options (Caelyx, paclitaxel, or topotecan). The doctors will carefully track how the cancer responds and look for any side effects. This will help them decide if this new drug could be a good treatment option in the future.
Key takeaways
- This study is testing a new drug for specific types of ovarian, primary peritoneal, or fallopian tube cancer.
- It's for women whose cancer has not responded to previous platinum-based chemotherapy.
- The new drug targets cancer cells in a specific way.
- You might receive the new drug or a standard chemotherapy.
- Doctors will carefully monitor your health and how the cancer responds.
- You can stop participating at any time.
Who may be eligible?
This study is specifically for women aged 18 or older.
You might be able to take part if you have a diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer, and your doctors have determined that your cancer is resistant to platinum-based chemotherapy. This means your cancer has either grown or returned within six months of your last platinum-based treatment.
There will be other detailed health checks to make sure this study is safe and right for you, but these are the main starting points for who can consider 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.
- I am a woman.
- I am 18 years old or older.
- I have been diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- My doctors have told me my cancer is resistant to platinum-based chemotherapy.
What does participation involve?
If you decide to take part in this study, you will receive one of the study treatments – either the new drug (farletuzumab ecteribulin) or a standard chemotherapy. The specific treatment you receive will be chosen randomly, like flipping a coin. You will have regular visits to the clinic for your treatment and to monitor your health. These visits will include tests such as blood tests, physical exams, and scans (like CT scans) to see how your cancer is responding and to check for any side effects. The doctors and nurses will explain the full schedule of visits and tests during your enrolment. The total duration of your participation will depend on how your cancer responds to the treatment and your general health, but it will involve ongoing assessments as long as you are receiving the study medication.
Potential risks and benefits
Locations (3)
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What does 'platinum-resistant' mean?
It means your cancer hasn't responded well or has started to grow again within six months after treatment with platinum-based chemotherapy drugs.
What is 'Phase 2' in a clinical trial?
Phase 2 is an early stage of testing where researchers check if a new treatment works and if it's safe enough to be studied further in a larger group of people.
Will I definitely get the new drug?
No, participants will be randomly assigned to either receive the new drug or one of the standard chemotherapy treatments, so it's a chance.
How will doctors know if the treatment is working?
They will use scans and other tests to see if your tumour shrinks or stops growing, and they will also monitor your general health.
Can I stop participating if I want to?
Yes, you are free to leave the study at any time without having to give a reason, and it won't affect your future medical care.
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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