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New treatment option for Advanced or Metastatic CRC
Official title Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06833866
What this study is testing
What is Hydroxytyrosol?
Hydroxytyrosol is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced or metastatic crc.
Also referred to as Folfiri/Folfox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A subject will be eligible for inclusion in this study only if all the following criteria are met:
- Male or female ≥18 years of age.
- Histopathologically or cytologically confirmed advanced or metastatic CRC.
- Patient who is eligible for first-line therapy for advanced or metastatic CRC, such as 5FU-based therapy.
- Measurable disease per the RECIST v1.1.
You likely can't join if
- people must meet all the inclusion criteria listed above in Section 10.1 and none of the following exclusion criteria:
- Hematology laboratory values of:
- WBC of \<3000 and absolute neutrophil count ≤1500 cells/mm3 with the Fy null phenotype.
- Platelets ≤100,000 cells/mm3
- Hemoglobin ≤9 g/dL (Fe infusion is allowed to correct anemia in iron deficient anemia patients, per standard-of-care)
- Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:
See the full eligibility criteria
- A subject will be eligible for inclusion in this study only if all the following criteria are met:
- Male or female ≥18 years of age.
- Histopathologically or cytologically confirmed advanced or metastatic CRC.
- Patient who is eligible for first-line therapy for advanced or metastatic CRC, such as 5FU-based therapy.
- Measurable disease per the RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy ≥6 months.
- 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...
- 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...
- people must meet all the inclusion criteria listed above in Section 10.1 and none of the following exclusion criteria:
- Hematology laboratory values of:
- WBC of \<3000 and absolute neutrophil count ≤1500 cells/mm3 with the Fy null phenotype.
- Platelets ≤100,000 cells/mm3
- Hemoglobin ≤9 g/dL (Fe infusion is allowed to correct anemia in iron deficient anemia patients, per standard-of-care)
- Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:
- \>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or
- \>2.5 × ULN if no liver metastases are present.
- Serum albumin \<2.8 g/dL.
- Total bilirubin \>1.5 × ULN or \>1.5 mg/dL.
- 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...
- Estimated glomerular filtration rate \<50 mL/min.
- Positive pregnancy test, pregnant, or breastfeeding (female patients only).
- Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.
- 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:
- Arrhythmia
- Bradycardia
- Tachycardia
- Symptomatic valvular disease
- Symptomatic congestive heart failure classified by the New York Heart Association as Class III or IV
- Unstable angina pectoris.
- Myocardial infarction within the past 6 months.
- Active bleeding diathesis (platelets less than 100,000 or active bleeding)
- Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months.
- Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other immunosuppressive agents
- Known history and/or uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.
- History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.
- 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...
- Receipt of any investigational agent or study treatment within the past 30 days.
- Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months.
- Patients must be able to swallow oral capsules.
- Participants with metastatic CRC and microsatellite instability-high or deficient mismatch repair tumors.
- surgical Surgery, within 12-months or less.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.