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NCT06833866 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
A Phase 1 study of Advanced or Metastatic CRC, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT06833866 is a Phase 1 study of Advanced or Metastatic CRC that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 33 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06833866, a Phase 1 study of Advanced or Metastatic CRC, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
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. 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. The 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
Conditions Studied
Interventions
- DRUG Hydroxytyrosol
Study Locations (1)
Texas
- Houston Methodist. - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2024-12-04 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06833866
The ClinicalTrials.gov registry entry for NCT06833866 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced or Metastatic CRC appearing as the primary indexed condition, and to 1 intervention - of which Hydroxytyrosol is the first listed.
NCT06833866 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06833866 about?
NCT06833866 is a clinical study titled "Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer". 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. Patients will receive: 1 capsule of HT 25 mg daily for 2 weeks...
What is the current status of trial NCT06833866?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2024-12-04. Estimated completion is 2025-12-01.
What conditions does trial NCT06833866 study?
This clinical trial studies the following conditions: Advanced or Metastatic CRC.
What interventions are being tested in trial NCT06833866?
The interventions under investigation include: Hydroxytyrosol (DRUG).
Who is sponsoring clinical trial NCT06833866?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06833866 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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