Stivarga Regulatory Post-Marketing Surveillance Study in Korea

NCT02106858 | Completed

• 2 other identifiers: 16778SV1314KR
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Overall response

  Up to 6 years

• Progression free survival (PFS)

  Up to 6 years

• Overall survival (OS)

  Up to 6 years

Study Arms (1)

Group 1

Patients treated by Physician with Stivarga under approved local prescriptions

Drug: Regorafenib (Stivarga,BAY73-4506)

Interventions

Regorafenib (Stivarga,BAY73-4506) DRUG

Patients treated by Physician with Stivarga under approved local prescriptions

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, South Korea

Location

Related Links

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MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Gastrointestinal Stromal Tumors

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: June 25, 2014
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

KR (1)