Regorafenib Post-marketing Surveillance
Conditions
Colorectal Neoplasms
Conditions: official terms
Colorectal Neoplasms
Conditions: Keywords
Regorafenib, Colorectal Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: BAY73-4506_Regorafenib
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:Patients

- who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

- Patients who have previously received Regorafenib/ STIVARGA
Location
Many Locations, Japan
Status: Recruiting
Start Date
April 2013
Completion Date
March 2021
Sponsors
Bayer
Source
Bayer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page