A clinical trial is a medical research study that investigates a treatment or therapy in people. It helps doctors understand how safe the treatment is, how well it works, and how it might be used to help others.
“Investigational” means that the study treatment has not been approved for use for platinum-resistant ovarian cancer except in clinical trials.
This Phase 2 study is enrolling people with ovarian cancer who have experienced a recurrence within six months of completing platinum-based chemotherapy and whose tumors have Cyclin E1 overexpression.
Biomarker testing looks for specific features in your cancer cells that may help match you to a treatment. For this study, it uses tissue samples already collected by your physician, so no new biopsy is needed; only your consent for your samples to be used.
This Phase 2 study uses Cyclin E1 biomarker testing to help determine who may be eligible to participate. A small sample of tumor tissue will be analyzed to see whether your cancer expresses the Cyclin E1 biomarker, which plays a role in how cancer cells grow and divide.
Only patients whose tumors test positive for Cyclin E1 may be able to join the study. While other biomarkers, such as FRα (folate receptor alpha), are used for different types of therapies, only Cyclin E1 testing is relevant to this study’s enrollment process.
To find out, you’ll need to contact a participating trial site. They can help arrange testing of your previously collected tumor tissue to see if your tumor is CE1 positive.
No. There is no placebo arm, so every participant in this trial receives active therapy.
The trial duration runs up to approximately 12 months from the enrollment of the last participant.
Yes, you would need to visit a participating clinical trial site for an in-person assessment. You can find a trial site near you here.
No, there is no cost for trial participants.*
Before enrolling in the clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains written information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
You can ask questions of the study team at any time before, during, and after the study. Before agreeing to participate, make sure that you understand the responsibilities of study participants.
If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study doctor/staff at any time.
Study participation is completely voluntary. You do not need to take part in the study, and you can end your participation at any time, for any reason.
If you think you would like to stop participating in the study, talk to the study doctor/staff. If you decide you should leave the study early, the study doctor may ask that you return to the study center for a final visit to ensure your health and safety, but there will be no negative impact on future care you receive.
You can visit any doctor to meet your health needs during the study. You should let your study doctor know that you will be seeing another doctor and if any other medication has been prescribed. You should also let your other doctors know that you are participating in a clinical research study.
Taking part in a clinical trial has both potential benefits and risks. A medical professional will explain everything you need to know, including possible side effects and what to expect during the study. While over 100 patients have participated to date, this treatment is still being studied for platinum-resistant ovarian cancer and has not been approved by any regulatory authorities, so not everything is known yet. It’s important to understand this before deciding to join. If you have questions or concerns, talk to your doctor or care team.