CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 760 enrolled
Drug / intervention
Regorafenib (Stivarga, BAY73-4506) +2 moredrug
Likely dose
Regorafenib (Stivarga, BAY73-4506) 160 mgfrom 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/NCT01103323
NCT01103323Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

Bayer·interventional·Posted Apr 14, 2010·Updated Jun 24, 2015

In Brief

A Phase 3 clinical trial evaluating Regorafenib (Stivarga, BAY73-4506), Placebo, and 1 other intervention for Metastatic Colorectal Cancer. Completed, enrolled 760 participants across 171 sites in 19 countries.

Detailed Summary

This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Portugal, Spain, Switzerland, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2010
Enrollment StartApr 1, 2010
Primary CompletionJul 1, 2011
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.2 years ago

Interventions

Regorafenib (Stivarga, BAY73-4506)drug

160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

Placebodrug

matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

Best Supportive Care (BSC)other

BSC includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.