Stivarga Regulatory Post-Marketing Surveillance Study in Korea (StivargaPMS)

Bayer

Status: Completed

Conditions: Colorectal Neoplasms

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02106858

16778

SV1314KR (Other Identifier)

Details and patient eligibility

About

To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.

Enrollment: 316 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:
• Signed and dated informed consent
• Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician
• Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time
• Exclusion Criteria:
• Patients participating in an investigational program with interventions outside of routine clinical practice
• All contra-indications according to the local marketing authorization have to be considered.

Trial design

316 participants in 1 patient group

Group 1

Description:

Patients treated by Physician with Stivarga under approved local prescriptions

Treatment:

Drug: Regorafenib (Stivarga,BAY73-4506)