Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K)

Exclusion Criteria

• •* \[Interventional Treatments\]
• •Subjects who received an investigational product in another clinical trial within 14 days prior to the first administration of the investigational product in this study.
• •Subjects who received cytotoxic chemotherapy within 14 days prior to the first administration of the investigational product, or monoclonal antibody therapy within 4 weeks prior to the first administration of the investigational product.
• •Subjects who received radiotherapy involving more than 30% of the bone marrow within 4 weeks prior to the first administration of the investigational product, or palliative radiotherapy to a limited field within 2 weeks prior to the first administration.
• •Subjects with persistent toxicities ≥ Grade 1 according to CTCAE from prior anticancer therapy that have not resolved before the first administration of the investigational product (except for alopecia).
• •\[Medical History and Concurrent Diseases\]
• •Women who are pregnant or breastfeeding.
• •Subjects with active, severe, or uncontrolled infection.
• •Subjects with clinically significant cardiovascular disease, including but not limited to:
• •Acute coronary syndrome within 6 months
• •Congestive heart failure ≥ NYHA (New York Heart Association) Class II
• •QTc prolongation or uncontrolled hypertension
• •Other significant cardiovascular conditions (e.g., clinically significant arrhythmias or congenital long QT syndrome)
• •Subjects with progressive brain metastases, defined as unstable or symptomatic brain lesions.
• •Subjects whose lesions have been stable for at least 4 weeks following radiotherapy or surgery may be eligible for enrollment.
• •(Leptomeningeal metastasis is excluded.)
• •Subjects with active infections such as hepatitis B (HBV), hepatitis C (HCV), or HIV.
• •However, enrollment is permitted under the following conditions:
• •Subjects who are HBsAg positive may be enrolled if HBV DNA is below the lower limit of quantification according to local laboratory testing.
• •Subjects with chronic HBV infection (HBsAg positive and HBV DNA positive) may be enrolled if they have received antiviral therapy for at least 3 months and are considered not to have active hepatitis at the investigator's discretion.
• •Subjects with a history of previous HBV infection (IgG anti-HBc positive) may be enrolled if HBV DNA is below the lower limit of quantification.
• •Subjects who are anti-HCV antibody positive may be enrolled if HCV RNA is below the lower limit of quantification.
• •Subjects who underwent major surgery within 4 weeks prior to the first administration of the investigational product, or who have not adequately recovered from surgery.
• •Subjects with a history of thrombosis within 6 months prior to the first administration of the investigational product.
• •Subjects with a history or evidence of bleeding disorders.
• •Subjects who are receiving high-dose anticoagulant therapy for therapeutic purposes.
• •Subjects with non-healing wounds, active ulcers, or bone fractures.
• •Subjects with a history of gastrointestinal perforation, active gastrointestinal bleeding, or abdominal fistula within the past 6 months.
• •Subjects with proteinuria.
• •If the urine dipstick test shows ≥2+ proteinuria, a 24-hour urine protein test or urine protein/creatinine ratio (UPCR) should be performed.
• •Subjects will be excluded if:
• •24-hour urine protein \> 1 g, or
• •UPCR \> 1.0
• •Subjects with a history of surgery affecting drug absorption or with severe gastrointestinal disorders that may interfere with drug absorption.
• •Subjects with a history of another primary malignancy, except for:
• •Adequately treated non-melanoma skin cancer, or
• •Stage I cancer that has shown no recurrence for at least 36 months after curative resection
• •Subjects with known hypersensitivity to the active ingredient or excipients of the investigational product, including:
• •Hypersensitivity or allergy to Allura Red (relevant to Fruquintinib capsule 5 mg)
• •Hypersensitivity or allergy to Tartrazine (FD\&C Yellow No.5) or Sunset Yellow FCF (FD\&C Yellow No.6) (relevant to Fruquintinib capsule 1 mg)
• •Subjects who are scheduled to undergo major surgery during the study period.
• •Subjects who have medical, psychiatric, or cognitive conditions that may interfere with the understanding of study information, performance of study procedures, or provision of written informed consent.
• •Subjects who are considered inappropriate for participation in the study at the discretion of the Principal Investigator.