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Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy

NCT01939223 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-10-20

Study results available
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Summary

To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Regorafenib (Stivarga, BAY73-4506)

Four tablets of 40mg taken orally daily in the morning, dose of 160 mg for 21 days of treatment followed by 7 days without treatment

DRUG

Placebo

Four tablets taken in the morning orally daily for 21 days of treatment followed by 7 days without treatment

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-02
Primary Completion
2016-08-29
Completion
2016-08-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01939223 on ClinicalTrials.gov