Safety and Efficacy of Fruquintinib+FOLFIRI in RAS-mutated Metastatic Colorectal Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

August 10, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Combination: Fruquintinib + FOLFIRI

"Phase 1b Fruquintinib was administered in a 3 + 3 dose escalation regimen at the following doses: L1:3 mg/d, L2:4 mg/d, L3:5 mg/d.~Fruquintinib: QD po q2w~FOLFIRI regimen:~Irinotecan:180 mg/m2, i.v. , d1, q2w LV:200 mg/m2, i.v., d1, q2w 5-FU:2400 mg/m2, i.v.for over 46 hours, q2w~Phase II Fruquintinib: RP2D, QD po q2w~FOLFIRI regimen:~Irinotecan: 180 mg/m2, i.v. , d1, q2w LV: 200 mg/m2, i.v., d1, q2w 5-FU:2400 mg/m2, i.v.for over 46 hours, q2w"

Trial Locations (1)

Unknown

RECRUITING

Chinese PLA General Hospital, Beijing

All Listed Sponsors
collaborator

Hutchison Medipharma Limited

INDUSTRY

lead

Chinese PLA General Hospital

OTHER