Actively Recruiting
A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
Led by Takeda · Updated on 2026-02-27
78
Participants Needed
45
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written or electronic informed consent.
- Male or female aged 18 years or older.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma with documented RAS status.
- Previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
- Previously treated with an anti-vascular endothelial growth factor (VEGF) biologic therapy.
- If RAS wild-type and appropriate, previously treated with an anti-epidermal growth factor receptor (EGFR) therapy.
- If known MSI-H or dMMR tumor and appropriate, previously treated with a programmed cell death protein 1 (PD1) inhibitor.
- Self-identify as Black/African American and/or Hispanic/Latino.
- Body weight 40 kilograms or more.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
- Have assessable disease per RECIST version 1.1.
- Agree to use effective contraception if of childbearing potential throughout the study and for 2 weeks after last dose.
You will not qualify if you...
- Absolute neutrophil count below 1.5 x 10^9/L, platelet count below 100 x 10^9/L, or hemoglobin below 9.0 g/dL.
- Serum total bilirubin above 1.5 times upper limit of normal (ULN), except Gilbert syndrome with bilirubin below 2 times ULN.
- ALT or AST above 2.5 times ULN without liver metastases; above 5 times ULN with liver metastases.
- Creatinine clearance less than 30 mL/min.
- Proteinuria of 2+ or higher on urine dipstick or 1.0 g/24 hours or more in urine.
- Uncontrolled hypertension with systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg despite treatment.
- INR or aPTT above 1.5 times ULN unless on anticoagulants for prevention.
- History or active gastrointestinal ulcers, bleeding, perforation, or fistulas within 6 months.
- Hemorrhage from any site within 2 months.
- Thromboembolic events within 6 months.
- Stroke or transient ischemic attack within 12 months.
- Significant cardiovascular disease or low heart function.
- QTcF interval over 480 milliseconds or risk factors for arrhythmia.
- Recent systemic therapies or investigational treatments within specified time frames.
- Recent radiotherapy, brachytherapy, surgery, or invasive procedures within specified times.
- Unresolved toxicities greater than grade 1 except specified exceptions.
- Known HIV infection or active viral hepatitis unless controlled.
- Clinically uncontrolled infections requiring IV antibiotics.
- Tumor invading large blood vessels.
- Pregnancy or lactation.
- Untreated brain metastases or spinal cord compression.
- Other recent malignancies except certain treated cancers.
- Inability to take oral medication or severe gastrointestinal conditions affecting drug absorption.
- Conditions or disorders that may interfere with trial participation or safety.
- Known allergy to fruquintinib or its components including certain dyes.
- Previous exposure to fruquintinib.
- Live vaccines within 28 days before starting trial treatment.
- Use of strong CYP3A4 inducers within 2 weeks before starting treatment.
AI-Screening
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Trial Site Locations
Total: 45 locations
1
Central Alabama Research
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
3
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
Actively Recruiting
4
University of Arizona
Tucson, Arizona, United States, 85719
Actively Recruiting
5
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
6
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
7
PIH Health Whittier Hospital
Whittier, California, United States, 90602
Not Yet Recruiting
8
Christiana Care Health Services
Newark, Delaware, United States, 19713
Actively Recruiting
9
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
10
University of Miami
Miami, Florida, United States, 33146
Withdrawn
11
Baptist Health - Miami Cancer Institute
Miami, Florida, United States, 33176
Withdrawn
12
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Actively Recruiting
14
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
15
Our Lady of the Lake Physician Group - LSU Health Baton Rouge Oncology
Baton Rouge, Louisiana, United States, 70805
Actively Recruiting
16
Willis Knighton Cancer Center
Shreveport, Louisiana, United States, 71103
Actively Recruiting
17
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
18
Boston Medical Center
Boston, Massachusetts, United States, 02118
Withdrawn
19
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
20
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Withdrawn
21
Midwest Oncology Associates - Kansas City
Kansas City, Missouri, United States, 64132
Actively Recruiting
22
SSM Health St. Louis DePaul Hospital
St Louis, Missouri, United States, 63044
Actively Recruiting
23
Washington University School of Medicine
St Louis, Missouri, United States, 63108
Actively Recruiting
24
Capital Health Medical Center - Hopewell
Pennington, New Jersey, United States, 08534
Actively Recruiting
25
Columbia University
New York, New York, United States, 10032
Withdrawn
26
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
Withdrawn
27
James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York, United States, 10468
Withdrawn
28
Zangmeister Cancer Center
Columbus, Ohio, United States, 43219
Actively Recruiting
29
Hightower Clinical Research
Oklahoma City, Oklahoma, United States, 73102
Actively Recruiting
30
Jefferson Health
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
31
Fox Chase Cancer Center | Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19111
Withdrawn
32
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Withdrawn
33
University of Tennessee -- Memphis
Memphis, Tennessee, United States, 38163
Actively Recruiting
34
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
35
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
36
Renovatio Clinical
El Paso, Texas, United States, 79915
Actively Recruiting
37
Oncology Consultants - Memorial City Location
Houston, Texas, United States, 77030
Actively Recruiting
38
Baylor College of Medicine
Houston, Texas, United States, 77054
Actively Recruiting
39
BRCR Global
Katy, Texas, United States, 77450
Withdrawn
40
Renovatio Clinical
The Woodlands, Texas, United States, 77380
Actively Recruiting
41
Tranquil Research
Webster, Texas, United States, 77598
Actively Recruiting
42
UC Irvine Medical Center - Chao Family Comprehensive Cancer
Orange, Virginia, United States, 22960
Actively Recruiting
43
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
44
Medstar Speciality Hospital
Northwest, Washington, United States, 20010
Actively Recruiting
45
Fundacion de Investigacion de Diego (FDI Clinical Research)
San Juan, Puerto Rico, 00927
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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