Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Last updated: April 9, 2025
Sponsor: Lindsay Ferguson, MD
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Cervical Intraepithelial Neoplasia

Genitourinary Cancer

Treatment

Chemoradiation

Hysterectomy

Cervical Conization

Clinical Study ID

NCT06191133
CASE3822
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have histologically or cytologic confirmed high grade dysplasia orcervical cancer. Histologic types include squamous cell, adenocarcinoma oradenosquamous cell carcinoma.

  • Participants must be eligible for surgical management with LEEP, CKC or hysterectomyor 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 awritten informed consent document.

Exclusion

Exclusion Criteria:

  • Participants with active liver disease, including primary biliary cirrhosis andunexplained, liver function abnormality

  • Participants with severe kidney impairment (CrCl ≤30 mL/min calculated usingCockcroft-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 developingfetus/infant. Please note: Participants of child-bearing potential (have had menseswithin the past year or have not had total hysterectomy) are actively screened forpregnancy prior to diagnostic procedures and screened again prior to treatment.

Study Design

Total Participants: 24
Treatment Group(s): 4
Primary Treatment: Chemoradiation
Phase: 1
Study Start date:
November 20, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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