A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)

Inclusion criteria

• Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
• Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
• Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
• At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
• Key

Exclusion criteria

• Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
• Major surgery within 4 weeks of the first planned dose of study treatment
• More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
• Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
• Uncontrolled, symptomatic brain metastases
• Uncontrolled, symptomatic gastrointestinal disease
• Participants with uncontrolled hypertension
• Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy
• Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
• Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
• Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
• Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening