Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT06191133
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2023-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'D019092', 'term': 'Conization'}, {'id': 'D007044', 'term': 'Hysterectomy'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2023-12-20', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in p53 levels', 'timeFrame': 'Up to six weeks after study enrollment', 'description': 'Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery'}, {'measure': 'Change in tumor metabolic status', 'timeFrame': 'Up to six weeks after study enrollment', 'description': 'Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing'}], 'secondaryOutcomes': [{'measure': 'Fenofibrate tolerability', 'timeFrame': 'Up to six weeks after study enrollment', 'description': 'Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fenofibrate'], 'conditions': ['Cervical Intraepithelial Neoplasia', 'Invasive Cervical Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have histologically or cytologic confirmed high grade dysplasia or cervical cancer. Histologic types include squamous cell, adenocarcinoma or adenosquamous cell carcinoma.\n* Participants must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation\n* Age ≥ 18 years\n* Normal liver function (AST, ALT, bilirubin within institutional normal limits).\n* Participants must be English speaking\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants with active liver disease, including primary biliary cirrhosis and unexplained, liver function abnormality\n* Participants with severe kidney impairment (CrCl ≤30 mL/min calculated using Cockcroft-Gault), or end-stage kidney disease on dialysis\n* Participants with preexisting gallbladder disease including active gallstones\n* Known hypersensitivity to fenofibrate or fenofibric acid\n* 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.'}, 'identificationModule': {'nctId': 'NCT06191133', 'briefTitle': 'Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma', 'orgStudyIdInfo': {'id': 'CASE3822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Excisional procedure + Fenofibrate', 'description': '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', 'interventionNames': ['Drug: Fenofibrate', 'Procedure: Cervical Conization']}, {'type': 'EXPERIMENTAL', 'label': 'Hysterectomy or chemoradiation + fenofibrate', 'description': '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', 'interventionNames': ['Drug: Fenofibrate', 'Procedure: Hysterectomy', 'Radiation: Chemoradiation']}], 'interventions': [{'name': 'Fenofibrate', 'type': 'DRUG', 'otherNames': ['Antara', 'Fenoglide', 'Lipofen', 'Tricor', 'Triglide'], 'description': 'Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.', 'armGroupLabels': ['Excisional procedure + Fenofibrate', 'Hysterectomy or chemoradiation + fenofibrate']}, {'name': 'Cervical Conization', 'type': 'PROCEDURE', 'description': 'Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix', 'armGroupLabels': ['Excisional procedure + Fenofibrate']}, {'name': 'Hysterectomy', 'type': 'PROCEDURE', 'description': 'In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.', 'armGroupLabels': ['Hysterectomy or chemoradiation + fenofibrate']}, {'name': 'Chemoradiation', 'type': 'RADIATION', 'description': '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.', 'armGroupLabels': ['Hysterectomy or chemoradiation + fenofibrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsay A Ferguson, MD', 'role': 'CONTACT', 'email': 'lindsay.ferguson@uhhospitals.org', 'phone': '216-844-3954'}], 'facility': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Lindsay A Ferguson, MD', 'role': 'CONTACT', 'email': 'lindsay.ferguson@uhhospitals.org', 'phone': '216-844-3954'}], 'overallOfficials': [{'name': 'Lindsay Ferguson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lindsay Ferguson, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lindsay Ferguson, MD', 'investigatorAffiliation': 'Case Comprehensive Cancer Center'}}}}