Clinical trial · Observational
Regorafenib Post-marketing Surveillance
Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer
- 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)
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer. The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice. A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
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
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
Primary outcomes (2)
- measure
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
- timeFrame
- Up to 6 months
- measure
- Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
- timeFrame
- up to 6 months
Secondary outcomes (7)
- measure
- Number of pateints with ADRs in subpopulations
- timeFrame
- Up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria:Patients * who are determined to start Regorafenib/ STIVARGA treatment Exclusion Criteria: * Patients who have previously received Regorafenib/ STIVARGA
References
Publications (0)
Data not yet available