Clinical trial · Observational
Stivarga Regulatory Post-Marketing Surveillance Study in Korea
Stivarga® Regulatory Post-Marketing Surveillance Study in Korea
NCT02106858CI-TRIAL-00068197StivargaPMScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib (Stivarga,BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients treated by Physician with Stivarga under approved local prescriptions
- interventionNames
- Drug: Regorafenib (Stivarga,BAY73-4506)
Primary outcomes (2)
- measure
- Percentage of patients with serious adverse events
- timeFrame
- Up to 30 days after terminating treatment
- description
- Every 2 months (monthly safety assessment within first two cycles)
- measure
- Percentage of patients with adverse drug reactions (ADRs)
- timeFrame
- Up to 30 days after terminating treatment
- description
- Every 2 months (monthly safety assessment within first two cycles)
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
* 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.
References
Publications (0)
Data not yet available
No reference posted for this study.