RecruitingPhase 4NCT06562543

A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer

A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies


Sponsor

Takeda

Enrollment

78 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of fruquintinib — an oral targeted cancer drug — specifically in Black or African American and Hispanic or Latino patients with advanced colorectal cancer who have already received standard chemotherapy and targeted therapy, as these populations are often underrepresented in clinical trials. **You may be eligible if...** - You are 18 or older and self-identify as Black and/or African American, or Hispanic and/or Latino - You have confirmed metastatic colorectal cancer that has been treated with standard fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, and anti-VEGF therapy (and anti-EGFR therapy if applicable) - You have measurable disease and a good performance status (ECOG 0 or 1) - Your weight is at least 40 kg **You may NOT be eligible if...** - You have had a recent heart attack, stroke, blood clot, or serious bleeding - You have HIV or uncontrolled viral hepatitis - You have uncontrolled high blood pressure - You are pregnant or breastfeeding - You have previously received fruquintinib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFruquintinib

Oral capsules


Locations(45)

Central Alabama Research

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Ironwood Cancer and Research Centers

Chandler, Arizona, United States

University of Arizona

Tucson, Arizona, United States

University of California San Diego

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

PIH Health Whittier Hospital

Whittier, California, United States

Christiana Care Health Services

Newark, Delaware, United States

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Baptist Health - Miami Cancer Institute

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Our Lady of the Lake Physician Group - LSU Health Baton Rouge Oncology

Baton Rouge, Louisiana, United States

Willis Knighton Cancer Center

Shreveport, Louisiana, United States

Mercy Medical Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Midwest Oncology Associates - Kansas City

Kansas City, Missouri, United States

SSM Health St. Louis DePaul Hospital

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Capital Health Medical Center - Hopewell

Pennington, New Jersey, United States

Columbia University

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York, United States

Zangmeister Cancer Center

Columbus, Ohio, United States

Hightower Clinical Research

Oklahoma City, Oklahoma, United States

Jefferson Health

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center | Philadelphia, PA

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Tennessee -- Memphis

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Renovatio Clinical

El Paso, Texas, United States

Oncology Consultants - Memorial City Location

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

BRCR Global

Katy, Texas, United States

Renovatio Clinical

The Woodlands, Texas, United States

Tranquil Research

Webster, Texas, United States

UC Irvine Medical Center - Chao Family Comprehensive Cancer

Orange, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Medstar Speciality Hospital

Northwest, Washington, United States

Fundacion de Investigacion de Diego (FDI Clinical Research)

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06562543


Related Trials