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NCT Number: NCT06191133

Fenofibrate in Patients With 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.

Recruiting

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Invasive Cervical Cancer Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Lindsay A Ferguson, MD

CONTACT

[email protected]

216-844-3954

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fenofibrate

Drug

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: Antara, Fenoglide, Lipofen, Tricor, Triglide

cervical conization

Procedure

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

Hysterectomy

Procedure

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

Chemoradiation

Radiation

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 outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay A Ferguson, MD

CONTACT

[email protected]

216-844-3954

Sponsors and collaborators

Lead sponsor

Lindsay Ferguson, MD

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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