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A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
Sponsor: Takeda
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2025-01-14
Completion Date
2027-10-04
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Fruquintinib
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