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Fruquintinib for Advanced Colorectal Cancer in Minority Populations

This study is looking at fruquintinib, an oral capsule, for people from minority groups with advanced colorectal cancer that has been treated before. We want to understand if people from minority groups, like Black/African American and/or Hispanic/Latino individuals, have a higher risk of developing high blood pressure (hypertension) when taking fruquintinib. High blood pressure is a known side effect of this medication. We also want to learn how safe fruquintinib is and how well people tolerate it. You would take fruquintinib in 4-week cycles until your condition worsens or you can no longer tolerate the treatment. This study plans to enroll 78 participants.

Study design
This study is an interventional trial, meaning participants will receive a specific treatment. It plans to enroll 78 participants.
What's involved
Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they no longer tolerate the treatment, or stop for other reasons.
Compensation
Not stated in the trial record.
Follow-up
High blood pressure will be measured from the first dose of the study drug up to the end of the study, which is approximately 35 months.

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NCT06562543

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Takeda
~78 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Fruquintinib

At a glance

Recruiting sites
32 of 45 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment Emergent Grade 3 and Grade 4 Hypertension
Measured over From the first dose of the study drug up to end of study (approximately 35 months)

Conditions

Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

45 sites across 24 states
Texas7
Missouri4
California3
Florida3
New York3
Alabama2
Arizona2
Louisiana2

Study leadership

  • Study Director · STUDY_DIRECTOR · Takeda

Who to contact

Takeda Contact
[email protected]
+1-877-825-3327
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Number of Participants with Treatment Emergent Grade 3 and Grade 4 HypertensionFrom the first dose of the study drug up to end of study (approximately 35 months)

    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.