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NCT06562543 · ClinicalTrials.gov registry record · Phase 4
A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
A Phase 4 study of Colorectal Cancer, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 78
- Enrollment target
- 20
- Study locations
NCT06562543: Recruiting Phase 4 study of Colorectal Cancer, sponsored by Takeda.
NCT06562543 is a Phase 4 study of Colorectal Cancer that is actively recruiting participants, run by Takeda. The registered enrollment target is 78 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06562543, a Phase 4 study of Colorectal Cancer, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 78 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Fruquintinib
Study Locations (20)
California
- University of California San Diego - La Jolla
- University of Southern California - Los Angeles
- PIH Health Whittier Hospital - Whittier
Florida
- University of Florida - Gainesville
- University of Miami - Miami
- Baptist Health - Miami Cancer Institute - Miami
Alabama
- Central Alabama Research - Birmingham
- University of Alabama at Birmingham - Birmingham
Arizona
- Ironwood Cancer and Research Centers - Chandler
- University of Arizona - Tucson
Louisiana
- Our Lady of the Lake Physician Group - LSU Health Baton Rouge Oncology - Baton Rouge
- Willis Knighton Cancer Center - Shreveport
Delaware
- Christiana Care Health Services - Newark
Georgia
- Emory University - Atlanta
Illinois
- Hope and Healing Cancer Services - Hinsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2025-01-14 |
| Est. Completion | 2027-10-04 |
| Phase | Phase 4 |
What NCT06562543 shows while recruiting
NCT06562543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Fruquintinib is the first listed.
NCT06562543 names 20 study sites across 13 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06562543 about?
NCT06562543 is a clinical study titled "A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer". 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 highe...
What is the current status of trial NCT06562543?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 78 participants. The study started on 2025-01-14. Estimated completion is 2027-10-04.
What conditions does trial NCT06562543 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT06562543?
The interventions under investigation include: Fruquintinib (DRUG).
Who is sponsoring clinical trial NCT06562543?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06562543 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06562543's enrollment target sits among peer trials
78 235th of 381 higher than 145 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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