Regorafenib Post-marketing Surveillance

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)

• Registration Number: NCT01843400
• Lead Sponsor: Bayer

Brief Summary

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 colorectal cancer.

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

A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-22
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-30
• Primary Completion: 2016-09-12
• Study Completion: 2016-11-14
• Status Verified: 2018-07
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1301

Inclusion Criteria

Patients

• who are determined to start Regorafenib/ STIVARGA treatment

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Exclusion Criteria

• Patients who have previously received Regorafenib/ STIVARGA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Regorafenib (Stivarga, BAY73-4506)	-

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

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 12 months
Time to Treatment failure in subpopulations	Up to 12 months
Number of pateints with ADRs in subpopulations	Up to 6 months
Number of patients with SAEs in supopulations	Up to 6 months
Overall survival in subpopulations	Up to 12 months
Time to treatment failure (TTF)	Up to 12 months
Tumor response assessed by RECIST or physicians own evaluation	Up to 6 months	RECIST: Response Evaluation Criteria In Solid Tumors