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
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.
Arms & interventions
- DrugFruquintinib
Oral capsules
Outcome measures
Primary
Number of Participants with Treatment Emergent Grade 3 and Grade 4 Hypertension
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving the first dose of the study drug and within 30 days after the last dose of the study drug or the initiation of subsequent anti-cancer therapy, whichever occurs earlier. Severity (toxicity grade) for hypertension will be determined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: From the first dose of the study drug up to end of study (approximately 35 months)
Secondary
Number of Participants with TEAEs, Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and Deaths
Time frame: From the first dose of the study drug up to end of study (approximately 35 months)
Overall Survival (OS)
Time frame: Up to approximately 35 months
Progression Free Survival (PFS)
Time frame: Up to approximately 35 months
Confirmed Objective Response Rate (cORR)
Time frame: Up to approximately 35 months
Disease Control Rate (DCR)
Time frame: Up to approximately 35 months
Duration of Response (DOR)
Time frame: Up to approximately 35 months
Plasma Concentration for Fruquintinib
Time frame: Pre-dose (within 1 hour) on Day 21 of Cycles 1 and 2; 2 hours post-dose on Days 1 and 21 of Cycles 1 to 4 and 3 hours post-dose on Days 1 and 21 of Cycles 1 and 2 (cycle length=28 days)
Eligibility criteria
Study locations (44)
Central Alabama Research
Birmingham, Alabama, 35209
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224
University of Arizona
Tucson, Arizona, 85719
University of California San Diego
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
PIH Health Whittier Hospital
Whittier, California, 90602
Christiana Care Health Services
Newark, Delaware, 19713
University of Florida
Gainesville, Florida, 32610
University of Miami
Miami, Florida, 33146
Baptist Health - Miami Cancer Institute
Miami, Florida, 33176
Emory University
Atlanta, Georgia, 30322
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Indiana University
Indianapolis, Indiana, 46202
Our Lady of the Lake Physician Group - LSU Health Baton Rouge Oncology
Baton Rouge, Louisiana, 70805
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
Mercy Medical Center
Baltimore, Maryland, 21202
Boston Medical Center
Boston, Massachusetts, 02118
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Midwest Oncology Associates - Kansas City
Kansas City, Missouri, 64132
SSM Health St. Louis DePaul Hospital
St Louis, Missouri, 63044
Washington University School of Medicine
St Louis, Missouri, 63108
Capital Health Medical Center - Hopewell
Pennington, New Jersey, 08534
Columbia University
New York, New York, 10032
Albert Einstein College of Medicine
The Bronx, New York, 10461
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, 10468
Zangmeister Cancer Center
Columbus, Ohio, 43219
Hightower Clinical Research
Oklahoma City, Oklahoma, 73102
Jefferson Health
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center | Philadelphia, PA
Philadelphia, Pennsylvania, 19111
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Tennessee -- Memphis
Memphis, Tennessee, 38163
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Renovatio Clinical
El Paso, Texas, 79915
Oncology Consultants - Memorial City Location
Houston, Texas, 77030
Baylor College of Medicine
Houston, Texas, 77054
BRCR Global
Katy, Texas, 77450
Renovatio Clinical
The Woodlands, Texas, 77380
Tranquil Research
Webster, Texas, 77598
UC Irvine Medical Center - Chao Family Comprehensive Cancer
Orange, Virginia, 22960
Virginia Commonwealth University
Richmond, Virginia, 23298
Medstar Speciality Hospital
Northwest, Washington, 20010