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NCT06562543PHASE4Recruiting

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

Takeda

Start Date

1/14/2025

Completion Date

10/4/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Provide written (or electronic) informed consent. 2. Male or female aged more than or equal to (≥)18 years. 3. Presence of histologically and/or cytologically documented metastatic colorectal adenocarcinoma. Rat sarcoma virus (RAS) status for each participant must be documented. 4. Have been previously treated with standard approved therapies: * Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, * An anti-vascular endothelial growth factor (VEGF) biological therapy (e.g., bevacizumab, aflibercept, ramucirumab \[regorafenib is NOT an anti-VEGF biologic\]), and * If RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy (e.g., cetuximab, panitumumab). * If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor. 5. Self-identify as Black and/or African American or Hispanic and/or Latino or as both. 6. Body weight ≥40 kilograms (kg). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening. 8. Have assessable disease according to RECIST version 1.1, assessed locally. 9. In participants of childbearing potential, agreement to use highly effective form(s) of contraception, which results in a low failure rate (less than \[\<\]1 percent \[%\] per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire trial period, and for 2 weeks after taking the last dose of the trial intervention. Such methods include oral (PO) hormonal contraception (combined estrogen/progestogen or progestogen-only) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Those assigned male sex at birth must always use a condom. Exclusion Criteria: 1. Absolute neutrophil count (ANC) \<1.5 times 10\^9 per liter (10\^9/L), platelet count \<100 times 10\^9/L, or hemoglobin \<9.0 grams per deciliter (g/dL). Blood transfusion within 1 week prior to enrollment for the purpose of increasing the likelihood of eligibility is not allowed. 2. Serum total bilirubin more than (\>)1.5 times the upper limit of normal range (ULN). Participants with previously documented Gilbert syndrome and bilirubin \<2 times ULN are eligible. 3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 times ULN in participants without hepatic metastases; ALT or AST \>5 times ULN in participants with hepatic metastases. 4. Creatinine clearance \<30 milliliters per minute (mL/min). Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation. Where available and appropriate, other formulae may be used to estimate clearance after consultation with the trial medical monitor. 5. Urine dipstick or urinalysis with protein ≥2 positive or 24-hour urine protein ≥1.0 gram per 24 hours (g/24 hours). Participants with 1+ positive proteinuria must undergo a 24-hour urine collection to assess urine protein level. 6. Uncontrolled hypertension, defined as systolic BP ≥140 millimeter of mercury (mmHg) and/or diastolic blood pressure (BP) ≥90 mmHg despite optimal medical management. The participant must have BP below both limits. Repeated assessments are permitted. 7. International normalized ratio (INR) \>1.5 times ULN or activated partial thromboplastin time (aPTT) \>1.5 times ULN, unless the participant is currently receiving or intended to receive anticoagulants for prophylactic purposes. 8. History of or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas, or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation within the 6 months prior to screening. 9. History or presence of hemorrhage from any other site (e.g, hemoptysis or hematemesis) within 2 months prior to screening. 10. History of a thromboembolic event, including deep vein thrombosis, pulmonary embolism, or arterial embolism within 6 months prior to screening. 11. Stroke and/or transient ischemic attack within 12 months prior to screening. 12. Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction \<50% by echocardiogram. 13. QT interval, corrected using the Fridericia method (QTcF) \>480 milliseconds or any factors that increase the risk of QT interval, corrected based on the patient's heart rate (QTc) prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, or family history of long QT syndrome. 14. Systemic antineoplastic therapies (except for that described in exclusion criterion no. 15) or any investigational therapy within 2 weeks prior to the first dose of the trial intervention, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy, and immunotherapy. 15. Systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors \[TKIs\]) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of the trial intervention. 16. Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of the trial intervention. 17. Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of the trial intervention. 18. Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 14 days prior to the first dose of the trial intervention or unhealed surgical incision. 19. Any unresolved toxicities from previous antitumor treatments greater than NCI CTCAE, version 5.0, Grade 1 (except for alopecia or neurotoxicity Grade less than or equal to \[≤\]2). 20. Known human immunodeficiency virus infection. 21. Known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load had to be undetectable on suppressive therapy, if indicated. Participants with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load. 22. Clinically uncontrolled active infection requiring intravenous (IV) antibiotics. 23. Tumor invasion of a large vascular structure (e.g., pulmonary artery or superior or inferior vena cava). 24. Those who are currently pregnant or lactating. 25. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of SD for 14 days or longer; participants requiring steroids within 4 weeks prior to the start of the trial intervention are to be excluded. 26. Other malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma, or bladder carcinoma (tumor in situ and T1) that had been adequately treated during the 5 years prior to screening. Participants with another primary malignancy that has been adequately treated may be included after consultation with the trial medical monitor. 27. Inability to take medication PO, dysphagia, or an active gastric ulcer resulting from previous surgery (e.g., gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe might affect absorption of the investigational medicinal product (IMP). 28. Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect might prohibit use of the IMP, affect interpretation of trial results, or put the participant at undue risk of harm based on the investigator's assessment. 29. Known hypersensitivity to fruquintinib or any of its inactive ingredients, including the azo dyes Tartrazine- Federal Food, Drug, and Cosmetic Act (FD\&C) Yellow 5 and Sunset yellow For Coloring Food (FCF)-FD\&C Yellow 6. 30. Received prior fruquintinib. 31. Live vaccine ≤28 days before the first dose of the trial intervention. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed. 32. Use of strong inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose of the trial intervention.

Interventions

DRUG

Fruquintinib

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Conditions

Colorectal Cancer

Locations

Central Alabama Research

Birmingham, Alabama 35209

United States

University of Alabama at Birmingham

Birmingham, Alabama 35249

United States

Ironwood Cancer and Research Centers

Chandler, Arizona 85224

United States

University of Arizona

Tucson, Arizona 85719

United States

University of California San Diego

La Jolla, California 92093

United States

University of Southern California

Los Angeles, California 90033

United States

PIH Health Whittier Hospital

Whittier, California 90602

United States

Christiana Care Health Services

Newark, Delaware 19713

United States

University of Florida

Gainesville, Florida 32610

United States

University of Miami

Miami, Florida 33146

United States

Baptist Health - Miami Cancer Institute

Miami, Florida 33176

United States

Emory University

Atlanta, Georgia 30322

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521

United States

Indiana University

Indianapolis, Indiana 46202

United States

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

Baton Rouge, Louisiana 70805

United States

Willis Knighton Cancer Center

Shreveport, Louisiana 71103

United States

Mercy Medical Center

Baltimore, Maryland 21202

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Hattiesburg Clinic

Hattiesburg, Mississippi 39401

United States

Saint Luke's Cancer Institute

Kansas City, Missouri 64111

United States

Midwest Oncology Associates - Kansas City

Kansas City, Missouri 64132

United States

SSM Health St. Louis DePaul Hospital

St Louis, Missouri 63044

United States

Washington University School of Medicine

St Louis, Missouri 63108

United States

Capital Health Medical Center - Hopewell

Pennington, New Jersey 08534

United States

Columbia University

New York, New York 10032

United States

Albert Einstein College of Medicine

The Bronx, New York 10461

United States

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York 10468

United States

Zangmeister Cancer Center

Columbus, Ohio 43219

United States

Hightower Clinical Research

Oklahoma City, Oklahoma 73102

United States

Jefferson Health

Philadelphia, Pennsylvania 19107

United States

Fox Chase Cancer Center | Philadelphia, PA

Philadelphia, Pennsylvania 19111

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

University of Tennessee -- Memphis

Memphis, Tennessee 38163

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37212

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Renovatio Clinical

El Paso, Texas 79915

United States

Oncology Consultants - Memorial City Location

Houston, Texas 77030

United States

Baylor College of Medicine

Houston, Texas 77054

United States

BRCR Global

Katy, Texas 77450

United States

Renovatio Clinical

The Woodlands, Texas 77380

United States

Tranquil Research

Webster, Texas 77598

United States

UC Irvine Medical Center - Chao Family Comprehensive Cancer

Orange, Virginia 22960

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States

Medstar Speciality Hospital

Northwest, Washington 20010

United States

Fundacion de Investigacion de Diego (FDI Clinical Research)

San Juan, 00927

Puerto Rico