At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
Regorafenib +1 moredrug
Likely dose
Regorafenib 160mgfrom 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 Two Arm Safety Study of Regorafenib Before or After SIR-Spheres Microspheres (90Y) for the Treatment of Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases
In Brief
A Phase 2 clinical trial evaluating SIR-Spheres and Regorafenib for Colorectal Neoplasms. Completed, enrolled 26 participants across 3 sites.
Detailed Summary
The purpose of this study is to determine the safety of regorafenib, an antiangiogenic drug, when combined with radioembolization using SIR-Spheres® microspheres in the treatment of colorectal cancer (CRC) that has spread to the liver.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesUnited States
CollaboratorsSirtex Medical
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedJul 2014
Primary CompletionJun 2017
TodayJul 2026
First PostedJul 21, 2014
Enrollment StartJul 1, 2014
Primary CompletionJun 4, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.9 years ago
Interventions
SIR-Spheresdevice
Radioembolization will be administered once by injection through a trans-femoral catheter into the hepatic artery.
Regorafenibdrug
All patients will take regorafenib 160mg orally once daily on Days 1-21 of each 28-day cycle.