Regorafenib Post-marketing Surveillance in Japan

Completed

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)

• Registration Number: NCT01933958
• Lead Sponsor: Bayer

Brief 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.

Study Timeline

• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-02
• Study Start: 2013-09-04
• Primary Completion: 2021-03-29
• Study Completion: 2021-10-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Regorafenib (Stivarga, BAY73-4506)	Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
tumour response	Up to 3 years
overall survival (OS)	Up to 3 years
time to treatment failure (TTF)	Up to 3 years	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.
Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.	Up to 3 years	Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR)