Regorafenib Post-marketing Surveillance in Japan

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

Detailed Description
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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.

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

Conditions
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Gastrointestinal Stromal Tumors

Intervention / Treatment
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* Drug: Regorafenib (Stivarga, BAY73-4506)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy. | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib. |  | Up to 6 months | 
| Number of patients with serious adverse events(SAEs) from the first administration of regorafenib. |  | Up to 6 months | 
| Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | Up to 3 years | 
| time to treatment failure (TTF) | TTF is defined as the time interval from start of Regorafenib/ STIVARGA therapy to the date of permanent discontinuation for any reason including disease progression, adverse event, patient preference or death. | Up to 3 years | 
| tumour response |  | Up to 3 years | 
| Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor. | Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR) | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regorafenib, Gastrointestinal stromal tumors