Regorafenib Post-marketing Surveillance

Bayer

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Drug: Regorafenib (Stivarga, BAY73-4506)

Study type: Observational

Funder types: Industry

Identifiers

NCT01843400

16472

STIVARGA-CRC-01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,301 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Patients

• who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

• Patients who have previously received Regorafenib/ STIVARGA

Trial design

1,301 participants in 1 patient group

Group 1

Treatment:

Drug: Regorafenib (Stivarga, BAY73-4506)