NCT01933958

Regorafenib Post-marketing Surveillance in Japan

Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Regorafenib (Stivarga, BAY73-4506)	The usual dosage is 160 mg of Regorafenib/ STIVARGA taken orally after meal once daily for 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.

Timeline

• Start date: 2013-09-04
• Primary completion: 2021-03-29
• Completion: 2021-10-29
• First posted: 2013-09-02
• Last updated: 2022-04-01

Locations

1 site across 1 country: Japan