What is the TAK-113-4002 Study?

This is a Phase 4 study to learn more about an approved cancer drug. Researchers are studying how the drug affects blood pressure in Black/African American and Latino/Hispanic adults with metastatic colorectal cancer (mCRC). mCRC is Stage 4 cancer.

Support may be available to help make participation easier, such as compensation for your time and reimbursement for travel.

Why is this research study being done?

High blood pressure is a common side effect with this cancer drug. The data collected up to this point suggest that Black/African American and Latino/Hispanic adults are not at greater risk for an increase in blood pressure.

This study may help doctors better understand the risk of high blood pressure in Black/African American and Latino/Hispanic adults with mCRC who are treated with this drug.

Who can participate?

Adults with Stage 4 colorectal cancer are invited to see if they may qualify for the study.

Age

Adults 18 years of age or older

Treatment

Have tried at least 2 cancer treatments before

Ethnicity

Black/African American or Latino/Hispanic

Diagnosis

Stage 4 (metastatic) colorectal cancer

Other

There are other requirements. The study doctor will check to see if you qualify for the study.

Treatment is given in 4-week cycles. The cancer drug is taken daily by mouth for 3 weeks, followed by a 1-week break.

For the first 3 cycles, participants will visit the study clinic on Day 1 and Day 21 of each cycle. For Cycle 4 and beyond, participants will visit the study clinic on Day 1.

What health checks and tests can I expect?

At study visits, participants may have health checks and tests to monitor their cancer and check for side effects.

Stethoscope icon, Physical exam, colorectal cancer, stage 4, metastatic, TAK-113-4002 Study

Physical
exam

Blood pressure cuff icon, Vital signs, colorectal cancer, stage 4, metastatic, TAK-113-4002 Study

Vital
signs

Blood drop and collection tube icon, Blood tests, colorectal cancer, stage 4, metastatic, TAK-113-4002 Study

Blood
tests

Urine collection cup icon, Urine tests, colorectal cancer, stage 4, metastatic, TAK-113-4002 Study

Urine
test

Pregnancy dipstick test icon, Pregnancy test if applicable, colorectal cancer, stage 4, metastatic, TAK-113-4002 Study

Pregnancy test
(if applicable)

Heart icon with a heartbeat line in the center, ECG heart test, colorectal cancer, stage 4, metastatic, TAK-113-4002 Study

ECG heart
test

Echocardiogram or MUGA heart test, colorectal cancer, stage 4, metastatic, Black, Latino, TAK-113-4002 Study

Echo or MUGA
heart test

MRI Icon, Tumor scans at 8-week intervals, colorectal cancer, stage 4, metastatic, TAK-113-4002 Study

Tumor scans
(at 8-week
intervals)

ECG = electrocardiogram
Echo = echocardiogram
MUGA = multigated acquisition

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