Recruiting
Phase 1

Fenofibrate

Sponsor:

Lindsay Ferguson, MD

Code:

NCT06191133

Conditions

Cervical Intraepithelial Neoplasia

Invasive Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fenofibrate

Cervical Conization

Hysterectomy

Chemoradiation

Study Details

Brief 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

Cervical Intraepithelial Neoplasia

Invasive Cervical Cancer

Study ID

NCT06191133

Start date

Nov 20, 2024

Status verified date

Sep, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must have histologically or cytologic confirmed high grade dysplasia or cervical cancer. Histologic types include squamous cell, adenocarcinoma or adenosquamous cell carcinoma.
  • Participants must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation
  • Age ≥ 18 years
  • Normal liver function (AST, ALT, bilirubin within institutional normal limits).
  • Participants must be English speaking
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants with active liver disease, including primary biliary cirrhosis and unexplained, liver function abnormality
  • Participants with severe kidney impairment (CrCl ≤30 mL/min calculated using Cockcroft-Gault), or end-stage kidney disease on dialysis
  • Participants with preexisting gallbladder disease including active gallstones
  • Known hypersensitivity to fenofibrate or fenofibric acid
  • Participants that are pregnant or breast feeding due to unknown risk to developing fetus/infant. Please note: Participants of child-bearing potential (have had menses within the past year or have not had total hysterectomy) are actively screened for pregnancy prior to diagnostic procedures and screened again prior to treatment.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Excisional procedure + Fenofibrate

Participants with high-grade dysplasia will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their excisional procedure

experimental: Hysterectomy or chemoradiation + fenofibrate

Participants with invasive cervical cancer will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their definitive hysterectomy or chemoradiation

Interventions

Fenofibrate

Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.

Cervical Conization

Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix

Hysterectomy

In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.

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.

Primary outcome measure

  • Change in p53 levels [ Time Frame: Up to six weeks after study enrollment ]
  • Change in tumor metabolic status [ Time Frame: Up to six weeks after study enrollment ]

Central Contacts and Locations

Central contacts

Lindsay A Ferguson, MD

216-844-3954lindsay.ferguson@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Lindsay A Ferguson, MD

216-844-3954lindsay.ferguson@uhhospitals.org

More Information

Sponsor

Lindsay Ferguson, MD

Last update posted

Jul 27, 2026

Last verified

Sep, 2025

Keywords

  • Fenofibrate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lindsay Ferguson, MD on 2026-07-27.