Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

NCT ID: NCT06191133

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2026-11-30

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.

Conditions

Cervical Intraepithelial Neoplasia; Invasive Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fenofibrate

Intervention Type: DRUG

Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.

Cervical Conization

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Fenofibrate

Intervention Type: DRUG

Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.

Hysterectomy

Intervention Type: PROCEDURE

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

Chemoradiation

Intervention Type: 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.

Interventions

Fenofibrate

Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.

Intervention Type: DRUG

Cervical Conization

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

Intervention Type: PROCEDURE

Hysterectomy

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

Intervention Type: PROCEDURE

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.

Intervention Type: RADIATION

Other Intervention Names

Antara; Fenoglide; Lipofen; Tricor; Triglide

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lindsay Ferguson, MD

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Ferguson, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lindsay Ferguson, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsay A Ferguson, MD

Role: CONTACT

lindsay.ferguson@uhhospitals.org

216-844-3954

Facility Contacts

Lindsay A Ferguson, MD

Role: primary

lindsay.ferguson@uhhospitals.org

216-844-3954

Other Identifiers

CASE3822

Identifier Type: -

Identifier Source: org_study_id