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.
Clinical trials are performed under control of regulatory authorities and are necessary before approval of a new therapy by the regulatory authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
“Investigational” means that the study treatment has not been approved for use for platinum-resistant ovarian cancer except in clinical trials.
The DENALI 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. This study uses tissue samples already collected by your physician, so no new biopsy is needed; only your consent for your samples to be used.
This 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 Cyclin E1 positive.
A placebo is a treatment that has no active properties. It is used in some clinical trials as a control.
Every participant in the DENALI trial receives active therapy.
The trial duration runs up to approximately 12 months from the enrollment of the last participant.
Yes, you will need to visit a participating clinical trial site for an in-person assessment. You can find a trial site near you here.
The costs related to participating in a clinical trial are often covered by insurance, if available, or by the study sponsor. In some cases, there may be additional expenses. The study coordinator can review the details with you and explain which costs are covered.
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 the study team questions at any time before, during, and after the study. Before agreeing to participate, make sure that you understand the responsibilities of study participants.
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 or 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 healthcare needs during the study. Taking part in the trial does not limit your ability to receive care outside of the study.
It’s important to let your study doctor know if you see other healthcare providers or if any new medications are prescribed. You should also let your care providers you see know that you are participating in a clinical research study.
Taking part in a clinical trial has 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.
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. If you have questions or concerns, talk to your doctor or care team.