NCT06191133RecruitingPhase 1
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 20 Dec 2023
- Start date
- 20 Nov 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Lindsay Ferguson, MD
- Diseases
- Cervical cancer
- NCT number
- NCT06191133
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 20 Nov 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.