Trials / Recruiting
RecruitingNCT06191133
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Lindsay Ferguson, MD · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Normally, p53 helps prevent tumors from forming in the body. Early studies have shown that Fenofibrate, a cholesterol-lowering drug, can restore normal function to p53 and can change the metabolism of HPV-positive tumors in a way that stops the growth of tumors. The purpose of this study is to understand how Fenofibrate can be used to treat HPV-positive cervical cancers and cervical dysplasia. Researchers will examine collected tissue samples and investigate various genes and proteins to see whether Fenofibrate has an effect on HPV-positive cervical cancers and cervical dysplasia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fenofibrate | Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use. |
| PROCEDURE | Cervical Conization | Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix |
| PROCEDURE | Hysterectomy | In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed. |
| RADIATION | Chemoradiation | Chemotherapy uses anti cancer (cytotoxic) drugs to destroy cancer cells. The drugs circulate throughout the body in the bloodstream. Radiotherapy uses high energy waves similar to x-rays to kill cancer cells. |
Timeline
- Start date
- 2024-11-20
- Primary completion
- 2026-06-30
- Completion
- 2026-11-30
- First posted
- 2024-01-05
- Last updated
- 2025-10-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06191133. Inclusion in this directory is not an endorsement.