CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 416 enrolled
Drug / intervention
fruquintinib +1 moredrug
Likely dose
fruquintinib 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02314819
NCT02314819Phase 3Completed
CompareCT.gov

A Randomized, Double-blind and Placebo-controlled Phase III Trial Comparing Fruquintinib Efficacy and Safety vs Best Support Care (BSC) in Advanced Colorectal Cancer Patients Who Have Failed at Least Second Lines of Chemotherapies

Hutchison Medipharma Limited·interventional·Posted Dec 11, 2014·Updated Feb 17, 2020

In Brief

A Phase 3 clinical trial evaluating fruquintinib and placebo for Colorectal Cancer. Completed, enrolled 416 participants across 15 sites.

Detailed Summary

Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase 2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after second line or above standard chemotherapy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesChina
CollaboratorsFudan University, Eighty-One Hospital of People's Liberation Army

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 11, 2014
Enrollment StartDec 1, 2014
Primary CompletionJan 1, 2017
Study CompletionJan 17, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.6 years ago

Interventions

fruquintinibdrug

fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off

placebodrug

fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off