Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Recruiting now · Phase 1

Conditions studied: Cervical Intraepithelial Neoplasia, Invasive Cervical Cancer

In brief

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.

Key facts

Study ID

NCT06191133

Run by

Lindsay Ferguson, MD

People needed

24

Starts

2024-11-20

Expected to finish

2026-12-30

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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