At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 691 enrolled
Drug / intervention
Fruquintinib +1 moredrug
Likely dose
Not stated in 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.
A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer
In Brief
A Phase 3 clinical trial evaluating Fruquintinib and Placebo for Metastatic Colorectal Cancer and Metastatic Colon Cancer. Completed, enrolled 691 participants across 153 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Czechia, Estonia, France, Germany, Hungary, Italy, Japan, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartAug 2020
Primary CompletionJul 2022
Study CompletionApr 2024
TodayJul 2026
First PostedMar 26, 2020
Enrollment StartAug 12, 2020
Primary CompletionJul 29, 2022
Study CompletionApr 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.3 years ago
Interventions
Fruquintinibdrug
Oral VEGFR inhibitor
Placebodrug
Placebo capsule