What is fruquintinib studying for colorectal cancer?

Fruquintinib is being studied to understand how often adults from minority groups develop high blood pressure after treatment for refractory metastatic colorectal cancer. Researchers are also evaluating the safety and tolerability of this oral medication. This study is sponsored by Takeda and focuses on underrepresented populations.

Who may be eligible for this colorectal cancer clinical trial?

Adults aged 18 years or older with metastatic colorectal adenocarcinoma who identify as Black/African American or Hispanic/Latino may be eligible. Participants must have received prior standard treatments and have controlled blood pressure below 140/90 mmHg. Please review eligibility criteria for more details.

Is there any cost to participate in this colorectal cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID06562543

Phase 4 Study of Oral Fruquintinib Safety and Effectiveness in Minority Adults With Previously Treated Advanced Metastatic Colorectal Cancer

Led by Takeda · Updated on 2026-07-07

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to understand how often adults from minority groups, such as BlackAfrican American and HispanicLatino individuals, experience high blood pressure after treatment with fruquintinib for refractory metastatic colorectal cancer. The study also evaluates the safety and tolerability of fruquintinib in these populations. This trial focuses on adults with metastatic colorectal adenocarcinoma who have previously received standard therapies and belong to underrepresented minority groups. Participants will take fruquintinib capsules orally at a dose of 5 mg once daily for the first 21 days of each 28-day cycle. Treatment continues until the disease worsens, unacceptable side effects occur, or participants choose to stop. After completing treatment, participants will have follow-up visits every three months until the study ends, which is expected to be about 35 months after the first dose. Throughout the study, participants will be monitored for the development of high-grade hypertension as the primary outcome. Safety will be assessed by tracking adverse events, overall survival, disease progression, and treatment response. Blood samples will be collected to measure fruquintinib levels at specified times. Regular assessments include evaluations of disease status and side effects, with monitoring continuing after treatment ends to ensure participant well-being during the entire study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

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) therapy.
If RAS wild-type and appropriate, previously treated with an anti-epidermal growth factor receptor (EGFR) therapy.
If MSI-H or dMMR tumor and appropriate, previously treated with a programmed cell death protein 1 (PD1) inhibitor.
Self-identify as Black/African American or Hispanic/Latino.
Body weight of at least 40 kilograms.
ECOG performance status of 0 to 1 at screening.
Have assessable disease per RECIST version 1.1.
Agree to use highly effective contraception if of childbearing potential during and 2 weeks after treatment.

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 more than 1.5 times upper limit of normal (ULN), except Gilbert syndrome with bilirubin under 2 times ULN.
ALT or AST over 2.5 times ULN without liver metastases or over 5 times ULN with liver metastases.
Creatinine clearance below 30 mL/min.
Proteinuria of 2+ or higher by urine dipstick or 1.0 gram/24 hours or more.
Uncontrolled hypertension above 140/90 mmHg despite treatment.
INR or aPTT over 1.5 times ULN unless on anticoagulants for prevention.
Recent history of gastrointestinal ulcers, bleeding, perforation, or fistulas within 6 months.
Recent hemorrhage from any site within 2 months.
Thromboembolic event within 6 months.
Stroke or transient ischemic attack within 12 months.
Significant cardiovascular disease including recent heart attack or heart failure.
QTcF interval over 480 milliseconds or risk factors for arrhythmia.
Recent systemic antineoplastic or investigational therapies within specified timeframes.
Recent palliative radiotherapy, brachytherapy, surgery, or invasive procedures within defined periods.
Unresolved toxicities from prior treatments above Grade 1.
Known HIV infection or active viral hepatitis without controlled viral load.
Active infection needing intravenous antibiotics.
Tumor invasion of large blood vessels.
Pregnant or breastfeeding.
Untreated or unstable brain metastases.
Other recent malignancies except certain treated cancers.
Inability to take oral medication or gastrointestinal conditions affecting drug absorption.
Other medical or metabolic conditions that increase risk or affect trial results.
Known allergy to fruquintinib or its ingredients.
Prior treatment with fruquintinib.
Live vaccine within 28 days before starting treatment.
Use of strong CYP3A4 inducers within 2 weeks before treatment.

Research Team

Takeda Contact

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Phase 4 Study of Oral Fruquintinib Safety and Effectiveness in Minority Adults With Previously Treated Advanced Metastatic Colorectal Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria