Stivarga Regulatory Post-Marketing Surveillance Study in Korea (StivargaPMS)

Stivarga® Regulatory Post-Marketing Surveillance Study in Korea

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Drug: Regorafenib (Stivarga,BAY73-4506)

• Study Type: Observational
• Enrollment (Actual): 316

Contacts and Locations

Study Locations

• Korea, Republic of
  • Multiple Locations, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with metastatic colorectal cancer or metastatic or unresectable locally advanced GIST(Gastrointestinal stromal tumors) by physician.

Description

• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients treated by Physician with Stivarga under approved local prescriptions	Drug: Regorafenib (Stivarga,BAY73-4506); Patients treated by Physician with Stivarga under approved local prescriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with serious adverse events	Every 2 months (monthly safety assessment within first two cycles)	Up to 30 days after terminating treatment
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 Outcome Measures

Outcome Measure	Time Frame
Overall response	Up to 6 years
Progression free survival (PFS)	Up to 6 years
Overall survival (OS)	Up to 6 years

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2014
• Primary Completion (Actual): May 7, 2019
• Study Completion (Actual): May 7, 2019

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimated): April 8, 2014

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 16778; SV1314KR (Other Identifier: Company Internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No