A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
This Phase 3 clinical trial looks at a new drug called azenosertib for women with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. It is designed for patients whose cancer has come back after standard platinum-based chemotherapy (known as platinum-resistant cancer) and whose tumour cells have high levels of a protein called Cyclin E1. In the trial, half of the participants will receive azenosertib, while the other half will receive one of four standard chemotherapy medicines chosen by their doctor. The main goal is to find out whether azenosertib can keep the cancer from growing for longer compared to standard chemotherapy. Researchers will also monitor overall survival, tumour shrinkage, and how the treatments affect day-to-day quality of life and common symptoms.
At a glance
What is this study about?
Ovarian, fallopian tube, and primary peritoneal cancers are closely related and often treated in similar ways. Standard treatment usually begins with surgery and chemotherapy containing platinum drugs. However, for many women, the cancer eventually returns and stops responding well to these initial medicines. When this happens, doctors describe the cancer as 'platinum-resistant', and finding effective new treatments becomes very important.
This trial investigates a new medicine called azenosertib. Azenosertib is a targeted therapy designed to disrupt how cancer cells divide and repair themselves. It is being studied specifically in tumours that produce higher amounts of a protein called Cyclin E1, which helps cancer cells grow. By blocking this process, researchers hope azenosertib can slow down or stop tumour growth more effectively than current options.
Because this is a Phase 3 study, doctors are directly comparing azenosertib to standard chemotherapy treatments already used in hospitals, such as paclitaxel, topotecan, doxorubicin, or gemcitabine. The results will help doctors understand if azenosertib offers a better, longer-lasting treatment option and how it impacts patients' everyday well-being.
Key takeaways
- Tests a new targeted medicine, azenosertib, against standard chemotherapy options.
- Aimed at women with advanced ovarian, fallopian tube, or peritoneal cancer.
- Designed for tumours that have returned after platinum chemotherapy and test positive for Cyclin E1.
- A Phase 3 study comparing treatment effectiveness, survival, and quality of life.
- Participation is voluntary and you can withdraw at any time without losing standard care.
Who may be eligible?
This study is open to women aged 18 and older who have been diagnosed with high-grade serous cancer of the ovary, fallopian tube, or peritoneum.
To be considered, your cancer must be 'platinum-resistant'. This generally means the cancer has started growing again within six months of finishing platinum chemotherapy. Your tumour must also test positive for the Cyclin E1 protein, which the study team can check using a sample of your cancer tissue.
You will also need to be well enough to carry out daily activities and have adequate kidney, liver, and bone marrow function. Your hospital doctor or the trial team can run standard tests to see if this trial is safe and suitable for you.
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 aged 18 or older.
- I have high-grade serous cancer of the ovary, fallopian tube, or peritoneum.
- My cancer has returned or progressed after platinum-based chemotherapy.
- I am willing to have my tumour tissue tested for the Cyclin E1 protein.
- I am well enough to attend regular hospital appointments and scans.
What does participation involve?
If you take part, you will be randomly assigned by a computer to receive either azenosertib or a standard chemotherapy chosen by your doctor. You will have regular hospital visits for treatment, blood tests, and health checks. If you take azenosertib, you will take it as tablets or capsules, and you may also receive anti-sickness medication to help prevent nausea. Regular CT or MRI scans will be done every few weeks to check how your tumour is responding. You will also be asked to fill in simple questionnaires about your symptoms and quality of life. You will stay on the study treatment for as long as it helps you and the side effects remain manageable.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedIreland
Common questions
What does 'platinum-resistant' mean?
It means the cancer has started to grow or return within six months of receiving standard platinum-based chemotherapy drugs, such as carboplatin or cisplatin.
Can I choose to receive azenosertib instead of chemotherapy?
No. A computer randomly decides which treatment group you join to ensure the trial results are fair and unbiased. Neither you nor your doctor can choose the group.
How do doctors check for the Cyclin E1 protein?
The trial team will usually test a small sample of tumour tissue that was already collected during a previous surgery or biopsy, so you might not need a new procedure.
Will taking part cost me anything?
No. The trial medicine and any extra study tests are provided free of charge, though you may need to travel to the trial hospital for visits.
What happens if I decide I want to stop?
You can leave the trial at any point. Your care will simply continue with standard NHS treatments recommended by your oncologist.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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