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Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma

NCT01774344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 573

Last updated 2020-08-20

Study results available
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Summary

The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Regorafenib (Stivarga, BAY73-4506)

Regorafenib, 40 mg tablets

DRUG

Placebo

Placebo tablets matching in appearance

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
2013-05-14
Primary Completion
2016-02-29
Completion
2019-07-05
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • 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 NCT01774344 on ClinicalTrials.gov