Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

September 29, 2025 updated by: Lindsay Ferguson, MD

Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Tricor
  • Fenoglide
  • Lipofen
  • Triglide
  • Antara
Procedure: Cervical Conization
Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
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
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.
Other Names:
  • Tricor
  • Fenoglide
  • Lipofen
  • Triglide
  • Antara
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in p53 levels
Time Frame: Up to six weeks after study enrollment
Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery
Up to six weeks after study enrollment
Change in tumor metabolic status
Time Frame: Up to six weeks after study enrollment
Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing
Up to six weeks after study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fenofibrate tolerability
Time Frame: Up to six weeks after study enrollment
Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment
Up to six weeks after study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lindsay Ferguson, MD

Investigators

  • Principal Investigator: Lindsay Ferguson, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE3822

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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