Study on Belzutifan for Recurrent Clear Cell Ovarian Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT06677190
This clinical trial is testing the safety and effectiveness of a new drug called Belzutifan for women with recurrent or persistent clear cell ovarian cancer. Belzutifan is a targeted therapy that aims to stop cancer cells from growing and spreading.
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Program Overview
The purpose of this study is to find out if Belzutifan, a drug that targets specific molecules in cancer cells, is safe and effective for treating women with recurrent or persistent clear cell ovarian cancer. Although Belzutifan is not yet approved for ovarian cancer, it has been approved for other uses. Participants will undergo various procedures, including medical tests and scans, to monitor their health and the drug's effects. Up to 32 women will participate in this study, which is supported by Merck & Company.
Description
This study is an open-label, non-randomized trial, meaning all participants will receive the same treatment without being randomly assigned to different groups. Belzutifan is a targeted therapy designed to attack specific molecules that cancer cells need to grow. While it is not yet approved for ovarian cancer, it has shown promise in other conditions. Participants will have regular clinic visits, undergo tests like ECGs, CT and MRI scans, and provide blood and urine samples. The study aims to include up to 32 women with recurrent or persistent clear cell ovarian cancer. Merck & Company is providing the drug and funding for this research.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of recurrent or persistent clear cell ovarian cancer, with at least 50% clear cell component if mixed.
- Must have measurable disease, meaning at least one tumor that can be accurately measured.
- Must have received at least one prior platinum-based chemotherapy treatment.
- Previous treatments with bevacizumab or immunotherapy are allowed.
- No limit on the number of previous treatments for recurrent or persistent cancer.
- Must be 18 years or older.
- Must have a performance status indicating they are fully active or have some restrictions but can still perform light work.
- Must have adequate organ and bone marrow function, as shown by specific blood test results.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 30 days after.
- Must be able to swallow pills and understand the study requirements, agreeing to sign a consent form.
Exclusion Criteria
- Previous treatment with Belzutifan or similar drugs.
- Low oxygen levels or need for supplemental oxygen.
- Recent cancer treatments within the last 4-6 weeks, depending on the type.
- Use of certain herbal supplements or medications that interact with the study drug.
- Participation in another clinical trial within the last 4 weeks.
- Unresolved side effects from previous cancer treatments, except for hair loss or mild nerve damage.
- Recent major surgery or gastrointestinal issues affecting medication absorption.
- Significant heart problems or liver impairment.
- Use of certain growth factors within 28 days before starting the study.
- Known HIV or active hepatitis B or C infections.
- Uncontrolled illnesses or psychiatric conditions that could interfere with the study.
- Pregnant or breastfeeding women.
- History of severe allergic reactions to similar drugs.
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