Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 4

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

NCT ID: NCT06562543Sponsor: TakedaLast updated: 2026-05-20

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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (44)

Central Alabama Research

Birmingham, Alabama, 35209

Recruiting
Khaleel Ashraf · Principal Investigator

University of Alabama at Birmingham

Birmingham, Alabama, 35249

Recruiting
Site Contact · Contact
Garima Gupta · Principal Investigator

Ironwood Cancer and Research Centers

Chandler, Arizona, 85224

Recruiting
Site Contact · Contact
Neel Dharia · Principal Investigator

University of Arizona

Tucson, Arizona, 85719

Recruiting
Site Contact · Contact
Aaron Scott · Principal Investigator

University of California San Diego

La Jolla, California, 92093

Recruiting
Site Contact · Contact
Gregory Botta · Principal Investigator

University of Southern California

Los Angeles, California, 90033

Recruiting
Site Contact · Contact
Sandra Algaze · Principal Investigator

PIH Health Whittier Hospital

Whittier, California, 90602

Recruiting
Andrew Pham · Principal Investigator

Christiana Care Health Services

Newark, Delaware, 19713

Recruiting
Site Contact · Contact
Jamal Misleh · Principal Investigator

University of Florida

Gainesville, Florida, 32610

Recruiting
Thomas George · Principal Investigator

University of Miami

Miami, Florida, 33146

Withdrawn

Baptist Health - Miami Cancer Institute

Miami, Florida, 33176

Withdrawn

Emory University

Atlanta, Georgia, 30322

Recruiting
Olatunji Alese · Principal Investigator

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521

Recruiting
Srilata Gundala · Principal Investigator

Indiana University

Indianapolis, Indiana, 46202

Recruiting
Site Contact · Contact
Anita Turk · Principal Investigator

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

Baton Rouge, Louisiana, 70805

Recruiting
Marshall Stagg · Principal Investigator

Willis Knighton Cancer Center

Shreveport, Louisiana, 71103

Recruiting
Site Contact · Contact
Joyce Feagin · Principal Investigator

Mercy Medical Center

Baltimore, Maryland, 21202

Recruiting
Site Contact · Contact
Panayotis Ledakis · Principal Investigator

Boston Medical Center

Boston, Massachusetts, 02118

Withdrawn

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401

Recruiting
John Hrom · Principal Investigator

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111

Withdrawn

Midwest Oncology Associates - Kansas City

Kansas City, Missouri, 64132

Recruiting
Jaswinder Singh · Principal Investigator

SSM Health St. Louis DePaul Hospital

St Louis, Missouri, 63044

Recruiting
Brian Smith · Principal Investigator

Washington University School of Medicine

St Louis, Missouri, 63108

Recruiting
Site Contact · Contact
Nikolaos Andreatos · Principal Investigator

Capital Health Medical Center - Hopewell

Pennington, New Jersey, 08534

Recruiting
Hongyan Liang · Principal Investigator

Columbia University

New York, New York, 10032

Withdrawn

Albert Einstein College of Medicine

The Bronx, New York, 10461

Withdrawn

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York, 10468

Withdrawn

Zangmeister Cancer Center

Columbus, Ohio, 43219

Recruiting
Sameh Mikhail · Principal Investigator

Hightower Clinical Research

Oklahoma City, Oklahoma, 73102

Completed

Jefferson Health

Philadelphia, Pennsylvania, 19107

Recruiting
Atrayee Basu-Mallick · Principal Investigator

Fox Chase Cancer Center | Philadelphia, PA

Philadelphia, Pennsylvania, 19111

Withdrawn

Medical University of South Carolina

Charleston, South Carolina, 29425

Withdrawn

University of Tennessee -- Memphis

Memphis, Tennessee, 38163

Recruiting
Site Contact · Contact
Saurin Chokshi · Principal Investigator

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Recruiting
Brooke Looney · Principal Investigator

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Recruiting
Nilesh Verma · Principal Investigator

Renovatio Clinical

El Paso, Texas, 79915

Recruiting
Mary Crow · Principal Investigator

Oncology Consultants - Memorial City Location

Houston, Texas, 77030

Recruiting
Julio Peguero · Principal Investigator

Baylor College of Medicine

Houston, Texas, 77054

Recruiting
Site Contact · Contact
Karen Riggins · Principal Investigator

BRCR Global

Katy, Texas, 77450

Withdrawn

Renovatio Clinical

The Woodlands, Texas, 77380

Recruiting
Jonathon Lu · Principal Investigator

Tranquil Research

Webster, Texas, 77598

Recruiting
Site Contact · Contact
John Knecht · Principal Investigator

UC Irvine Medical Center - Chao Family Comprehensive Cancer

Orange, Virginia, 22960

Recruiting
Site Contact · Contact
Farshid Dayyani · Principal Investigator

Virginia Commonwealth University

Richmond, Virginia, 23298

Recruiting
Khalid Matin · Principal Investigator

Medstar Speciality Hospital

Northwest, Washington, 20010

Recruiting
Marcus Noel · Principal Investigator