Trial Condition(s):
Colorectal Neoplasms
Stivarga Regulatory Post-Marketing Surveillance Study in Korea (StivargaPMS)
Bayer Identifier:
16778
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
316
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Stivarga® Regulatory Post-Marketing Surveillance Study in Korea
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Percentage of patients with serious adverse eventsEvery 2 months (monthly safety assessment within first two cycles)Timeframe: 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)Timeframe: Up to 30 days after terminating treatment
Secondary Outcome
- Overall responseTimeframe: Up to 6 years
- Progression free survival (PFS)Timeframe: Up to 6 years
- Overall survival (OS)Timeframe: Up to 6 years
Additional Information
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