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Fenofibrate for Cervical Cancer

Phase 1

Recruiting

Research Sponsored by Lindsay Ferguson, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to six weeks after study enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether a drug called Fenofibrate, which is used to lower cholesterol, can help treat certain types of cervical cancers and abnormal cervical cells caused by HPV infection. Early studies suggest

Who is the study for?

This trial is for English-speaking adults over 18 with high-grade cervical dysplasia or cervical cancer (squamous cell, adenocarcinoma, adenosquamous carcinoma) who are being treated at University Hospital Seidman Cancer Center. They must be eligible for surgical management or chemoradiation and able to give informed consent.

What is being tested?

Researchers are testing if Fenofibrate can treat HPV-positive cervical cancers and dysplasia by restoring p53 function and altering tumor metabolism. The study involves tissue sample analysis to observe the drug's effects on genes and proteins related to these conditions.

What are the potential side effects?

While not specified here, common side effects of Fenofibrate include digestive issues, liver enzyme changes, respiratory symptoms, back pain, headaches, increased risk of blood clots; specific side effects will be monitored in this context.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for surgery or chemoradiation as treatment.

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I am 18 years old or older.

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My cervical condition is confirmed as high grade dysplasia or cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to six weeks after study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to six weeks after study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to six weeks after study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in p53 levels

Change in tumor metabolic status

Secondary study objectives

Fenofibrate tolerability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Hysterectomy or chemoradiation + fenofibrateExperimental Treatment3 Interventions

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 II: Excisional procedure + FenofibrateExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hysterectomy

2021

Completed Phase 3

~1440

Fenofibrate

2018

Completed Phase 4

~6500