Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

NCT06191133 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CASE3822
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Fenofibrate

Outcome Measures

Primary Outcomes (2)

• Change in p53 levels

  Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery

  Up to six weeks after study enrollment

• Change in tumor metabolic status

  Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing

  Up to six weeks after study enrollment

Secondary Outcomes (1)

• Fenofibrate tolerability

  Up to six weeks after study enrollment

Study Arms (2)

Excisional procedure + Fenofibrate

EXPERIMENTAL

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

Drug: Fenofibrate; Procedure: Cervical Conization

Hysterectomy or chemoradiation + fenofibrate

EXPERIMENTAL

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

Drug: Fenofibrate; Procedure: Hysterectomy; Radiation: Chemoradiation

Interventions

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.

Also known as: Antara, Fenoglide, Lipofen, Tricor, Triglide

Excisional procedure + Fenofibrate; Hysterectomy or chemoradiation + fenofibrate

Cervical Conization PROCEDURE

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

Excisional procedure + Fenofibrate

Hysterectomy PROCEDURE

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

Hysterectomy or chemoradiation + fenofibrate

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.

Hysterectomy or chemoradiation + fenofibrate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Lindsay Ferguson, MD: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Fenofibrate; Conization; Hysterectomy; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Lindsay Ferguson, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay A Ferguson, MD

CONTACT

216-844-3954; lindsay.ferguson@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)