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NCT02106858 Clinical Trial

Stivarga Regulatory Post-Marketing Surveillance Study in Korea

Colorectal Neoplasms Clinical Trial

— StivargaPMS  

Official title:
Stivarga® Regulatory Post-Marketing Surveillance Study in Korea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02106858
Other study ID # 16778
Secondary ID SV1314KR
Status Completed
Phase
First received
Last updated
Start date June 25, 2014
Est. completion date May 7, 2019

Study information
Verified date July 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 316
Est. completion date May 7, 2019
Est. primary completion date May 7, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - 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 - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Regorafenib (Stivarga,BAY73-4506)
Patients treated by Physician with Stivarga under approved local prescriptions

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with serious adverse events Every 2 months (monthly safety assessment within first two cycles) Up to 30 days after terminating treatment
Primary Percentage of patients with adverse drug reactions (ADRs) Every 2 months (monthly safety assessment within first two cycles) Up to 30 days after terminating treatment
Secondary Overall response Up to 6 years
Secondary Progression free survival (PFS) Up to 6 years
Secondary Overall survival (OS) Up to 6 years
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