Status:
RECRUITING
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Lead Sponsor:
Lindsay Ferguson, MD
Conditions:
Cervical Intraepithelial Neoplasia
Invasive Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06191133
Start Date
November 20 2024
End Date
November 30 2026
Last Update
October 2 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106