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Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases

NCT02195011 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-12-05

Study results available
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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.

Conditions

  • Colorectal Neoplasms

Interventions

DEVICE

SIR-Spheres

Radioembolization will be administered once by injection through a trans-femoral catheter into the hepatic artery.

DRUG

Regorafenib

All patients will take regorafenib 160mg orally once daily on Days 1-21 of each 28-day cycle.

Sponsors & Collaborators

  • Sirtex Medical

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Andrew Kennedy, MD · SCRI Development Innovations, LLC

  • Johanna Bendell, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-06-04
Completion
2017-06-04
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195011 on ClinicalTrials.gov