Phase I Study of Hydroxytyrosol with Chemotherapy for Colorectal Cancer

This is a Phase I study looking at the safety and effects of combining Hydroxytyrosol (HT) with standard 5-Fluorouracil (5FU)-based chemotherapy (FOLFIRI/FOLFOX + Biologics) for people with advanced or metastatic colorectal cancer. You would take HT capsules daily for two weeks before starting chemotherapy, and continue taking them daily while on chemotherapy until your disease progresses. The main goal is to understand how safe this combination is, what side effects it might cause, and how your body handles the drugs. We are looking for about 33 participants who have advanced or metastatic colorectal cancer and are eligible for first-line 5FU-based therapy.

Study design
This is a Phase I interventional study planning to enroll 33 participants. The study is testing a combination of drugs.
What's involved
You would take Hydroxytyrosol capsules daily for two weeks before starting chemotherapy, and continue daily while receiving FOLFIRI/FOLFOX + Biologics chemotherapy until your disease progresses.
Compensation
Not stated in the trial record.
Follow-up
Your safety, toxicity, and how your body handles the drugs will be measured through study completion, up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06833866

Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
The Methodist Hospital Research Institute
~33 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Hydroxytyrosol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety, Toxicity, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of HT in Combination with FOLFIRI/FOLFOX + Biologics
Measured over Through study completion, up to 2 years
Advanced or Metastatic CRC
1 sites across 1 states
Texas1
  • Abdullah Esmail, MD · STUDY_DIRECTOR · Houston Methodist Neal Cancer Center
Jennifer Garrett M Clinical Trials Manager, MSN
Email the study team

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  • Safety, Toxicity, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of HT in Combination with FOLFIRI/FOLFOX + BiologicsThrough study completion, up to 2 years

    Evaluation of safety profile, toxicity, and PK/PD parameters in patients receiving HT with 5FU-based therapy according to NCI CTCAE v5.0.