Trials / Recruiting
RecruitingNCT06677190
Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Detailed 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-clinic visits, electrocardiograms (ECGs), Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, and blood and urine tests. It is expected up to 32 participants will take part in this research study. Merck \& Company is supporting this research study by providing funding and the study drug, Belzutifan.
Conditions
- Ovarian Cancer
- Ovarian Carcinoma
- Endometrial Cancer
- Uterine Cancer
- Cervical Cancer
- Vulvar Cancer
- Gynecologic Cancer
- Vaginal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belzutifan | A Hypoxia-Inducible Factor-2 alpha inhibitor, 40 mg immediate-release tablet, taken orally per protocol. |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2026-12-30
- Completion
- 2029-06-30
- First posted
- 2024-11-06
- Last updated
- 2025-11-05
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06677190. Inclusion in this directory is not an endorsement.