Trial Condition(s):
Colorectal Neoplasms
Regorafenib post-marketing surveillance
Bayer Identifier:
16472
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
Patients - who are determined to start Regorafenib/ STIVARGA treatment
Exclusion Criteria
- Patients who have previously received Regorafenib/ STIVARGA
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Drug Use Investigation of Regorafenib/ STIVARGA for unresectable, metastatic or recurrent colorectal cancer
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenibTimeframe: Up to 6 months
- Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.Timeframe: up to 6 months
Secondary Outcome
- Number of pateints with ADRs in subpopulationsTimeframe: Up to 6 months
- Number of patients with SAEs in supopulationsTimeframe: Up to 6 months
- Overall survival (OS)Timeframe: Up to 12 months
- Overall survival in subpopulationsTimeframe: Up to 12 months
- Time to treatment failure (TTF)Timeframe: Up to 12 months
- Time to Treatment failure in subpopulationsTimeframe: Up to 12 months
- Tumor response assessed by RECIST or physicians own evaluationRECIST: Response Evaluation Criteria In Solid TumorsTimeframe: Up to 6 months
Additional Information
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