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TAK-113-4002
Recruiting

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

Clinicaltrials.gov
#NCT06562543

About this clinical trial

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.

US
PR
Interventional Phase 4 clinical trial.

At a glance

What medical conditions are being studied?

Colorectal Cancer

What is the clinical trial testing?

Fruquintinib

How many participants are being enrolled?

78

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Jan 2025 - Feb 2028

How long is participation in the clinical trial?

Participants can be in study as long as they benefit from the treatment with fruquintinib or stop the treatment for other reasons. They will be followed until the study ends or they no longer want to participate.  

Key requirements

Sexes

All

Age

18+ Years

Healthy volunteers?

No

Entry criteria

Men and women can take part.
Must be 18 years or older.
Must have been diagnosed with metastatic colorectal cancer.
Must self-identify as Black and/or African American or Hispanic and/or Latino or as both.
Must weigh 40 kilograms (kg) or more.
Must have already been treated with standard therapies.
Cannot have uncontrolled high blood pressure (hypertension).
Cannot have stomach or bowel disorder.
Cannot have had heart problems.
Cannot have received fruquintinib earlier.
Additional entry criteria will be discussed with the study doctor.

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