drugset / Trial / NCT04322539

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer

Phase 3 Completed 691 enrolled Hutchison Medipharma Limited

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

Timeline

Start: 2020-08-12
Primary completion: 2022-07-29
Completion: 2024-04-24

Outcome

Met primary endpoint

registry analysis (superiority test); Fruquintinib + BSC Group vs Placebo + BSC Group; p < .001; Stratified Hazard Ratio 0.662 (95% CI 0.549 to 0.800); NCT04322539 ↗

release “today announces that the pivotal global Phase 3 FRESCO-2 trial evaluating the investigational use of fruquintinib met its primary endpoint of overall survival (“OS”)” hutch-med.com ↗

release “The MRCT FRESCO-2 study demonstrated that treatment with fruquintinib resulted in a statistically significant and clinically meaningful increase in the primary overall survival (“OS”) endpoint” hutch-med.com ↗

release “The FRESCO-2 study met its primary and key secondary endpoints” takeda.com ↗

release “FRESCO-2 met all of its primary and key secondary endpoints” hutch-med.com ↗

release “FRESCO-2 met all its primary and key secondary efficacy endpoints” takeda.com ↗