Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Phase 1

Recruiting

• Conditions: Invasive Cervical Cancer; Cervical Intraepithelial Neoplasia
• Interventions: Drug: Fenofibrate; Procedure: Hysterectomy; Procedure: Cervical Conization; Radiation: Chemoradiation

• Registration Number: NCT06191133
• Lead Sponsor: Lindsay Ferguson, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Study Start: 2024-11-20
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hysterectomy or chemoradiation + fenofibrate	Hysterectomy	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
Hysterectomy or chemoradiation + fenofibrate	Chemoradiation	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
Excisional procedure + Fenofibrate	Cervical Conization	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
Excisional procedure + Fenofibrate	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
Hysterectomy or chemoradiation + fenofibrate	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

Primary Outcome Measures

Name	Time	Method
Change in p53 levels	Up to six weeks after study enrollment	Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery
Change in tumor metabolic status	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 Outcome Measures

Name	Time	Method
Fenofibrate tolerability	Up to six weeks after study enrollment	Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States