Regorafenib Post-marketing Surveillance in Japan

Bayer

Status: Completed

Conditions: Gastrointestinal Stromal Tumors

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01933958

STIVARGA-GIST-01 (Other Identifier)

16732

Details and patient eligibility

About

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

Full description

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 gastrointestinal stromal tumors progressed after cancer chemotherapy.

A total of 135 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months and 24 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

Enrollment: 72 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are treated with Regorafenib/ STIVARGA and meet the product label.

Exclusion criteria

• Patients who are treated with Regorafenib/ STIVARGA and don't meet the product label.

Trial design

72 participants in 1 patient group

Group 1

Description:

Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy.

Treatment:

Drug: Regorafenib (Stivarga, BAY73-4506)