This study is being conducted to compare the effectiveness of a new drug called AZD5335 against other available treatments for individuals with Advanced Platinum-resistant Epithelial Ovarian Cancer. This type of cancer is a form of Ovarian Cancer where the disease has returned or continued to grow despite being treated with platinum-based medications. The study focuses on how much a specific protein, known as FRα, is present in the tumor cells. Patients are divided into groups based on whether they have high or low levels of this protein.
For those with a high amount of the protein, AZD5335 will be compared to mirvetuximab soravtansine. For those with a low amount of the protein, AZD5335 will be compared to a treatment chosen by the doctor, which may include doxorubicin hydrochloride, liposomal, topotecan, or paclitaxel. These treatments are delivered through an intravenous infusion, which means the medicine is passed directly into a vein.
During the study, participants will receive their assigned treatment and will be monitored to see how long the cancer remains stable without growing. This period is referred to as progression-free survival. The study also looks at overall survival, which is the total length of time from the start of the study until death from any cause.
Who Can Join the Study?
You must have a confirmed diagnosis of high-grade serous epithelial ovarian cancer (a specific type of ovarian cancer), primary peritoneal cancer (cancer starting in the lining of the abdomen), or fallopian tube cancer.
You must have platinum-resistant disease, which means the cancer has continued to grow or spread despite being treated with platinum-based therapies (a common type of chemotherapy).
If you have only had one previous treatment with platinum, you must have completed at least 4 cycles of that treatment, showed a positive response, and then had the cancer grow back between 3 and 6 months after your last dose.
If you have had 2 or 3 previous treatments with platinum, your cancer must have grown back within 6 months after your last dose.
Your cancer must have been shown to grow or spread on radiological imaging (such as a CT or MRI scan) after your most recent treatment.
You must have received at least one, but no more than three, previous systemic therapies (treatments that travel through the entire body, such as chemotherapy) to treat your cancer.
It must be appropriate for you to receive a single-agent therapy (a treatment using only one type of medicine) as your next step of care.
If you have a documented BRCA mutation (a change in the genes that can increase cancer risk), you must have previously taken PARP inhibitors (a type of targeted drug used to treat certain cancers) if it is recommended by medical guidelines, unless you cannot take them for medical reasons.
You must be able to provide an FFPE tumor tissue sample (a method where a small piece of tumor tissue is preserved in wax to be studied in a lab).
Who Cannot Join the Study?
You cannot join if your cancer is a specific type, such as endometrioid, clear cell, mucinous, sarcomatous, mixed tumours, low-grade, or borderline ovarian tumours, which refer to the specific way the cancer cells look under a microscope.
You cannot join if your cancer is primary platinum-refractory, which means the cancer did not respond to platinum-based chemotherapy or it grew back within 3 months after you finished your first round of that treatment.
You cannot join if you have active or long-term corneal disorders (problems with the clear front part of the eye), a history of corneal transplantation (eye surgery to replace the clear front part of the eye), or any eye conditions that need constant medical care.
You cannot join if you have signs or symptoms of a bowel obstruction, which is a blockage in the intestine that prevents food or liquid from passing through.
You cannot join if you have non-infectious ILD or pneumonitis, which are types of lung inflammation or scarring not caused by an infection, especially if you have needed steroids (strong anti-inflammatory medicine) or supplemental oxygen to breathe.
You cannot join if you have previously used any FRα-targeted therapy (medicine designed to attack a specific protein called FRα) or TOP1i ADC (a specific type of targeted drug).
You cannot join if you have had a major surgical procedure within 4 weeks before taking the first dose of the study medicine.
AZD5335 is the experimental treatment being tested in this study to see how well it works in treating certain types of ovarian cancer.
Mirvetuximab soravtansine is a medication used as a comparison to help determine the effectiveness of the experimental treatment in patients whose tumors have high levels of a specific protein.
Doxorubicin is a type of chemotherapy medication used as a comparison to help evaluate how the experimental treatment performs against standard cancer treatments.
Topotecan is a chemotherapy drug used as a comparison to help measure the effectiveness of the experimental treatment.
Paclitaxel is a chemotherapy medication used as a comparison to help assess the performance of the experimental treatment in patients.
Platinum-resistant epithelial ovarian cancer – This is a type of cancer that begins in the tissues of the ovaries. It is characterized by the disease continuing to grow or spreading despite having been treated with platinum-based medications. The condition involves the abnormal and uncontrolled growth of cells within the ovarian structure. As the disease progresses, these cancerous cells can spread to other parts of the abdomen or pelvis. The rate of spread may vary depending on the specific characteristics of the tumor cells.
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