Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-25 @ 2:30 PM
Study NCT ID:
NCT06833866
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005975', 'term': '3,4-dihydroxyphenylethanol'}, {'id': 'C410216', 'term': 'Folfox protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in Health-Related Quality of Life (QoL)', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': 'Assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).'}, {'measure': 'Immune T-Cell Profiling in Blood and Tissue Samples', 'timeFrame': 'Baseline, 2 weeks after HT initiation, and up to 100 weeks (from baseline to disease progression)', 'description': 'Analysis of T-cell clusters in pretreatment tissue and blood and on-treatment blood (after 2 weeks on HT alone).\n\nEvaluation of CD4+, CD8+ T cells, and CD8+ T-cell:Treg ratio using multiplexed IF \\& single-cell RNA sequencing (scRNA-seq).'}, {'measure': 'Assessment of Tissue Immune Cells', 'timeFrame': 'Baseline and post-treatment biopsy (up to 100 weeks, at disease progression or prior to surgery, if applicable)', 'description': 'Quantification of tissue immune cells using flow cytometry.'}, {'measure': 'Analysis of Regulatory Proteins and Plasma Cytokines', 'timeFrame': 'Baseline and post-treatment biopsy (up to 100 weeks, at disease progression or prior to surgery, if applicable)', 'description': 'Evaluation of regulatory proteins and plasma cytokines using a multiplexed protein array.'}], 'primaryOutcomes': [{'measure': 'Safety, Toxicity, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of HT in Combination with FOLFIRI/FOLFOX + Biologics', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'Evaluation of safety profile, toxicity, and PK/PD parameters in patients receiving HT with 5FU-based therapy according to NCI CTCAE v5.0.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) at 6 and 12 Months', 'timeFrame': '6 and 12 months post study drug initiation', 'description': 'Measurement of PFS at 6 months and 12 months, based on tumor assessment using RECIST v1.1 criteria.'}, {'measure': 'Objective Response Rate (ORR) According to RECIST v1.1', 'timeFrame': 'Through study completion, up to 2 years', 'description': 'Proportion of patients achieving partial response (PR) or complete response (CR) as per RECIST v1.1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer'], 'conditions': ['Advanced or Metastatic CRC']}, 'descriptionModule': {'briefSummary': 'This is a phase I study investigating the safety and antitumor activity of 5FU-based therapy (FOLFIRI/FOLFOX + Biologics) in combination with Hydroxytyrosol (HT) as a treatment for patients with advanced or metastatic colorectal cancer.\n\nPatients will receive: 1 capsule of HT 25 mg daily for 2 weeks before beginning 5FU-based therapy (FOLFIRI/FOLFOX + Biologics), 1 capsule of HT (25 mg) daily for 2 weeks while receiving the FOLFIRI/FOLFOX + Biologics, until sign of disease progression.\n\nThe prescribed FOLFIRI/FOLFOX administer as: Irinotecan 180 mg/m² intravenously (IV) over 90 minutes concurrently with Leucovorin 400 mg/m² IV over 120 minutes, followed by Fluorouracil 400-500 mg/m² IV bolus then 2400-3000 mg/m² IV infusion over 4-6 hours with or without, the designated Biologics, a standard dose of Cetuximab or Bevacizumab will be administered in 2-week cycles until disease progression or un-tolerated toxicity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA subject will be eligible for inclusion in this study only if all the following criteria are met:\n\n1. Male or female ≥18 years of age.\n2. Histopathologically or cytologically confirmed advanced or metastatic CRC.\n3. Patient who is eligible for first-line therapy for advanced or metastatic CRC, such as 5FU-based therapy.\n4. Measurable disease per the RECIST v1.1.\n5. Eastern Cooperative Oncology Group performance status of 0 or 1.\n6. Life expectancy ≥6 months.\n7. Females of childbearing potential must agree to use birth control during the study and for 30 days after your last dose of HT, at least 9 months after your last dose of oxaliplatin, at least 3 months after your last dose of 5-FU, and at least 6 months after your last dose of irinotecan.\n8. Male who are sexually active and their partner can become pregnant, must agree to use birth control during the study and for 30 days after their last dose of HT, at least 6 months after their last dose of oxaliplatin, at least 3 months after his last dose of 5-FU, and at least 3 months after his last dose of irinotecan.\n\n \\-\n\nExclusion Criteria:\n\nSubjects must meet all the inclusion criteria listed above in Section 10.1 and none of the following exclusion criteria:\n\n1. Hematology laboratory values of:\n\n 1. WBC of \\<3000 and absolute neutrophil count ≤1500 cells/mm3 with the Fy null phenotype.\n 2. Platelets ≤100,000 cells/mm3\n 3. Hemoglobin ≤9 g/dL (Fe infusion is allowed to correct anemia in iron deficient anemia patients, per standard-of-care)\n2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:\n\n 1. \\>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or\n 2. \\>2.5 × ULN if no liver metastases are present.\n3. Serum albumin \\<2.8 g/dL.\n4. Total bilirubin \\>1.5 × ULN or \\>1.5 mg/dL.\n5. Prothrombin time (PT) or international normalized ratio (INR) \\>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits.\n6. Estimated glomerular filtration rate \\<50 mL/min.\n7. Positive pregnancy test, pregnant, or breastfeeding (female patients only).\n8. Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.\n9. Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:\n\n 1. Arrhythmia\n 2. Bradycardia\n 3. Tachycardia\n 4. Symptomatic valvular disease\n 5. Symptomatic congestive heart failure classified by the New York Heart Association as Class III or IV\n 6. Unstable angina pectoris.\n10. Myocardial infarction within the past 6 months.\n11. Active bleeding diathesis (platelets less than 100,000 or active bleeding)\n12. Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months.\n13. Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other immunosuppressive agents\n14. Known history and/or uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.\n15. History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.\n16. Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month. Note: Influenza vaccine will be allowed if administered \\>21 days.\n17. Receipt of any investigational agent or study treatment within the past 30 days.\n18. Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months.\n19. Patients must be able to swallow oral capsules.\n20. Participants with metastatic CRC and microsatellite instability-high or deficient mismatch repair tumors.\n21. surgical Surgery, within 12-months or less.\n22. For patients to be treated with bevacizumab: history of gastrointestinal fistula or perforation, major surgery within 28 days of study treatment initiation, recent hemorrhage, arterial thromboembolic events or deep venous thrombosis within 6 months, uncontrolled hypertension (i.e., BP \\> 150/90 mm Hg), proteinuria, and hemoptysis.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT06833866', 'briefTitle': 'Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Pro00038031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxytyrosol (HT) in combination with Folfiri/Folfox', 'description': 'Patients will receive: 1 capsule of HT 25 mg daily for 2 weeks before beginning 5FU-based therapy (FOLFIRI/FOLFOX + Biologics), 1 capsule of HT (25 mg) daily for 2 weeks while receiving the FOLFIRI/FOLFOX + Biologics, until sign of disease progression.\n\nThe prescribed FOLFIRI/FOLFOX administer as: Irinotecan 180 mg/m² intravenously (IV) over 90 minutes concurrently with Leucovorin 400 mg/m² IV over 120 minutes, followed by Fluorouracil 400-500 mg/m² IV bolus then 2400-3000 mg/m² IV infusion over 4-6 hours with or without, the designated Biologics, a standard dose of Cetuximab or Bevacizumab will be administered in 2-week cycles until disease progression or un-tolerated toxicity', 'interventionNames': ['Drug: Hydroxytyrosol']}], 'interventions': [{'name': 'Hydroxytyrosol', 'type': 'DRUG', 'otherNames': ['Folfiri/Folfox'], 'description': 'Patients will receive: 1 capsule of HT 25 mg daily for 2 weeks before beginning 5FU-based therapy (FOLFIRI/FOLFOX + Biologics), 1 capsule of HT (25 mg) daily for 2 weeks while receiving the FOLFIRI/FOLFOX + Biologics, until sign of disease progression.\n\nThe prescribed FOLFIRI/FOLFOX administer as: Irinotecan 180 mg/m² intravenously (IV) over 90 minutes concurrently with Leucovorin 400 mg/m² IV over 120 minutes, followed by Fluorouracil 400-500 mg/m² IV bolus then 2400-3000 mg/m² IV infusion over 4-6 hours with or without, the designated Biologics, a standard dose of Cetuximab or Bevacizumab will be administered in 2-week cycles until disease progression or un-tolerated toxicity', 'armGroupLabels': ['Hydroxytyrosol (HT) in combination with Folfiri/Folfox']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Garrett M Clinical Trials Manager, MSN', 'role': 'CONTACT', 'email': 'jmgarrett@houstonmethodist.org', 'phone': '281-222-9983'}, {'role': 'CONTACT', 'email': 'aesmail@houstonmethodist.org'}, {'name': 'Maen Abdelrahim, MD, PhD. Pharm D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abdullah Esmail, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Houston Methodist.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jennifer Garrett M Clinical Trials Manager, MSN', 'role': 'CONTACT', 'email': 'jmgarrett@houstonmethodist.org', 'phone': '281-222-9983'}, {'name': 'Kimberly Vu Clinical Research Nurse, BSN', 'role': 'CONTACT', 'email': 'kvu2@houstonmethodist.org', 'phone': '936-270-2037'}], 'overallOfficials': [{'name': 'Abdullah Esmail, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Houston Methodist Neal Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maen Abdelrahim, MD, PhD, Pharm.B', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}