Study on the Safety and Effects of Fruquintinib in Minority Patients with Advanced Colorectal Cancer

Inclusion Criteria

• Must provide written or electronic consent to participate.
• Be 18 years or older.
• Have advanced colorectal cancer confirmed by lab tests.
• Have previously received standard treatments, including specific chemotherapy and biological therapies.
• Identify as Black/African American or Hispanic/Latino.
• Weigh at least 40 kilograms (about 88 pounds).
• Be in good general health with a performance status score of 0 or 1.
• Have cancer that can be measured by scans.
• Agree to use effective birth control during the study and for 2 weeks after the last dose if of childbearing potential.

Exclusion Criteria

• Low blood cell counts or hemoglobin levels.
• High bilirubin levels unless due to Gilbert syndrome.
• High liver enzyme levels, especially if cancer has spread to the liver.
• Poor kidney function.
• High levels of protein in urine.
• Uncontrolled high blood pressure.
• Blood clotting issues unless on anticoagulants.
• Recent history of stomach ulcers, bleeding, or other conditions that could cause bleeding.
• Recent history of blood clots or stroke.
• Significant heart disease or heart attack within the last 6 months.
• Long QT interval on an ECG or risk factors for heart rhythm issues.
• Recent cancer treatments or investigational therapies.
• Recent surgery or invasive procedures.
• Unresolved side effects from previous cancer treatments.
• Known HIV or active hepatitis infections.
• Active infections requiring IV antibiotics.
• Tumor invasion of major blood vessels.
• Pregnant or breastfeeding women.
• Untreated brain or spinal cord metastases.
• Other cancers within the last 5 years, except certain skin or cervical cancers.
• Difficulty swallowing or conditions affecting drug absorption.
• Allergies to fruquintinib or its ingredients.
• Previous treatment with fruquintinib.
• Recent live vaccinations.
• Use of certain medications affecting drug metabolism.