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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: Recruiting Phase 1 study of Advanced or Metastatic CRC, sponsored by The Methodist Hospital Research Institute.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Evaluation of safety profile, toxicity, and PK/PD parameters in patients receiving HT with 5FU-based therapy according to NCI CTCAE v5.0.
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 |
What NCT06833866 shows while recruiting
NCT06833866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06833866's enrollment target sits among peer trials
33 1281st of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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