A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
SCRI Development Innovations, LLC
60 participants
Sep 29, 2025
INTERVENTIONAL
Conditions
Summary
This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to: * Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting * Evaluate the safety of the combination of fruquintinib + FOLFIRI
Eligibility
Inclusion Criteria5
- 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 FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab- based first-line therapy for mCRC
- 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
Exclusion Criteria11
- 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 treatment received for mCRC prior to signing the ICFs
- Uncontrolled, symptomatic brain metastases
- Uncontrolled, symptomatic gastrointestinal disease
- Patients 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
Interventions
Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.
Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg/m2 intravenous infusion (IV), leucovorin 400 mg/m2 (or 200 mg/m2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus injection and 5-FU continuous IV infusion of 2400 mg/m2 over 46 to 48 hours.
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT07011576