Stivarga Regulatory Post-Marketing Surveillance Study in Korea

Completed

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

• Registration Number: NCT02106858
• Lead Sponsor: Bayer

Brief Summary

To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Study Start: 2014-06-25
• Primary Completion: 2019-05-07
• Study Completion: 2019-05-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

• Signed and dated informed consent
• Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician
• Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time

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Exclusion Criteria

• Patients participating in an investigational program with interventions outside of routine clinical practice
• All contra-indications according to the local marketing authorization have to be considered.

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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 by Physician with Stivarga under approved local prescriptions

Primary Outcome Measures

Name	Time	Method
Percentage of patients with serious adverse events	Up to 30 days after terminating treatment	Every 2 months (monthly safety assessment within first two cycles)
Percentage of patients with adverse drug reactions (ADRs)	Up to 30 days after terminating treatment	Every 2 months (monthly safety assessment within first two cycles)

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 6 years
Overall response	Up to 6 years
Progression free survival (PFS)	Up to 6 years