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

NCT06562543 | Recruiting Phase 4 FDA Drug

• 1 other identifier: TAK-113-4002
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 45

Brief 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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; fruquintinib

Outcome Measures

Primary Outcomes (1)

• 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.

  From the first dose of the study drug up to end of study (approximately 35 months)

Secondary Outcomes (7)

• Number of Participants with TEAEs, Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and Deaths

  From the first dose of the study drug up to end of study (approximately 35 months)

• Overall Survival (OS)

  Up to approximately 35 months

• Progression Free Survival (PFS)

  Up to approximately 35 months

• Confirmed Objective Response Rate (cORR)

  Up to approximately 35 months

• Disease Control Rate (DCR)

  Up to approximately 35 months

Study Arms (1)

Fruquintinib 5 mg

EXPERIMENTAL

Participants will receive fruquintinib capsule at a dose of 5 mg, orally (PO), once daily (QD), for the first 21 days of each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or other discontinuation criteria are met.

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

Oral capsules

Also known as: Fruzaqla™

Fruquintinib 5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written (or electronic) informed consent.
• Male or female aged more than or equal to (≥)18 years.
• Presence of histologically and/or cytologically documented metastatic colorectal adenocarcinoma. Rat sarcoma virus (RAS) status for each participant must be documented.
• 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.
• Self-identify as Black and/or African American or Hispanic and/or Latino or as both.
• Body weight ≥40 kilograms (kg).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.
• Have assessable disease according to RECIST version 1.1, assessed locally.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• History or presence of hemorrhage from any other site (e.g, hemoptysis or hematemesis) within 2 months prior to screening.
• History of a thromboembolic event, including deep vein thrombosis, pulmonary embolism, or arterial embolism within 6 months prior to screening.
• Stroke and/or transient ischemic attack within 12 months prior to screening.
• 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.
• 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.
• 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.
• Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of the trial intervention.

Sponsors & Collaborators

• Takeda: lead

Study Sites (45)

Central Alabama Research

Birmingham, Alabama, 35209, United States

RECRUITING

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Ironwood Cancer and Research Centers

Chandler, Arizona, 85224, United States

RECRUITING

University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

PIH Health Whittier Hospital

Whittier, California, 90602, United States

NOT YET RECRUITING

Christiana Care Health Services

Newark, Delaware, 19713, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

University of Miami

Miami, Florida, 33146, United States

WITHDRAWN

Baptist Health - Miami Cancer Institute

Miami, Florida, 33176, United States

WITHDRAWN

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

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

Baton Rouge, Louisiana, 70805, United States

RECRUITING

Willis Knighton Cancer Center

Shreveport, Louisiana, 71103, United States

RECRUITING

Mercy Medical Center

Baltimore, Maryland, 21202, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

WITHDRAWN

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

RECRUITING

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

WITHDRAWN

Midwest Oncology Associates - Kansas City

Kansas City, Missouri, 64132, United States

RECRUITING

SSM Health St. Louis DePaul Hospital

St Louis, Missouri, 63044, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

Capital Health Medical Center - Hopewell

Pennington, New Jersey, 08534, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

WITHDRAWN

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

WITHDRAWN

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York, 10468, United States

WITHDRAWN

Zangmeister Cancer Center

Columbus, Ohio, 43219, United States

RECRUITING

Hightower Clinical Research

Oklahoma City, Oklahoma, 73102, United States

RECRUITING

Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Fox Chase Cancer Center | Philadelphia, PA

Philadelphia, Pennsylvania, 19111, United States

WITHDRAWN

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

WITHDRAWN

University of Tennessee -- Memphis

Memphis, Tennessee, 38163, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Renovatio Clinical

El Paso, Texas, 79915, United States

RECRUITING

Oncology Consultants - Memorial City Location

Houston, Texas, 77030, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77054, United States

RECRUITING

BRCR Global

Katy, Texas, 77450, United States

WITHDRAWN

Renovatio Clinical

The Woodlands, Texas, 77380, United States

RECRUITING

Tranquil Research

Webster, Texas, 77598, United States

RECRUITING

UC Irvine Medical Center - Chao Family Comprehensive Cancer

Orange, Virginia, 22960, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Medstar Speciality Hospital

Northwest, Washington, 20010, United States

RECRUITING

Fundacion de Investigacion de Diego (FDI Clinical Research)

San Juan, 00927, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: January 14, 2025
• Primary Completion (Estimated): October 4, 2027
• Study Completion (Estimated): October 4, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (44); PR (1)