Clinical Trial

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

Study acronym: FRUITFUL
Recruiting Phase 2
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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
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2025-06-05; most recent amendment 2026-06-10.
Status change: Not Yet Recruiting → Recruiting 2025-08-07
Trial Details
NCT Number NCT07011576
Lead Sponsor SCRI Development Innovations, LLC
Collaborators: Takeda Development Center Americas, Inc.
Conditions Colon Cancer, Rectal Cancer, Colorectal Cancer, Colorectal Cancer (CRC)
Enrollment 60 participants
Start Date 2025-09-29
Primary Completion 2027-01 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-12