A Phase II Trial of Belzutifan in Patients With Recurrent or Persistent Clear Cell Carcinoma of the Ovary or Clear Cell Carcinoma of Other Gynecologic Origin
Dana-Farber Cancer Institute
Summary
The purpose of this research study is to see if the study drug Belzutifan is effective and safe for participants with clear cell gynecologic malignancy, including but not limited to, ovarian cancer, endometrial cancer, cervical cancer, vaginal cancer, vulvar cancer, or endometriosis-related cancer. The name of the study drug involved in this study is: \- Belzutifan (a type of Hypoxia-Inducible Factor-2 alpha (HIF-2a) inhibitor)
Description
This is an open label, non-randomized, single cohort, phase II trial of Belzutifan for participants with recurrent or persistent clear cell ovarian carcinoma (CCOC) and clear cell carcinoma of other gynecologic malignancies. Belzutifan is a targeted drug therapy, which is a type of cancer treatment that targets specific molecules that cancer cells need to grow and spread. The U.S. Food and Drug Administration (FDA) has not approved Belzutifan for ovarian cancer, or other gynecologic cancers, but it has been approved for other uses. The study procedures include screening for eligibility, in-c…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed recurrent or persistent clear cell carcinoma of the ovary (CCOC) or clear cell carcinoma of other gynecologic origin (e.g., endometrial, cervical, vaginal, vulvar, endometriosis-related). If mixed histology, then ≥50% clear cell component. * Participants must have measurable disease, defined as at least one lesion that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression h…
Interventions
- DrugBelzutifan
A Hypoxia-Inducible Factor-2 alpha inhibitor, 40 mg immediate-release tablet, taken orally per protocol.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts