Regorafenib Post-marketing Surveillance

August 1, 2018 updated by: Bayer

Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer.

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.

A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with unresectable, metastatic or recurrent colorectal cancer

Description

Inclusion Criteria:Patients

  • who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

  • Patients who have previously received Regorafenib/ STIVARGA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Regorafenib (Stivarga, BAY73-4506)
Patients treated with Regorafenib under practical manner for colorectal cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
Time Frame: Up to 6 months
Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 12 months
Up to 12 months
Number of pateints with ADRs in subpopulations
Time Frame: Up to 6 months
Up to 6 months
Number of patients with SAEs in supopulations
Time Frame: Up to 6 months
Up to 6 months
Overall survival in subpopulations
Time Frame: Up to 12 months
Up to 12 months
Time to treatment failure (TTF)
Time Frame: Up to 12 months
Up to 12 months
Time to Treatment failure in subpopulations
Time Frame: Up to 12 months
Up to 12 months
Tumor response assessed by RECIST or physicians own evaluation
Time Frame: Up to 6 months
RECIST: Response Evaluation Criteria In Solid Tumors
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2013

Primary Completion (Actual)

September 12, 2016

Study Completion (Actual)

November 14, 2016

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16472
  • STIVARGA-CRC-01 (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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