- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01843400
Regorafenib Post-marketing Surveillance
Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Multiple Locations, Japan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:Patients
- who are determined to start Regorafenib/ STIVARGA treatment
Exclusion Criteria:
- Patients who have previously received Regorafenib/ STIVARGA
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
|
Patients treated with Regorafenib under practical manner for colorectal cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
Time Frame: Up to 6 months
|
Up to 6 months
|
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
Time Frame: up to 6 months
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Up to 12 months
|
Up to 12 months
|
|
Number of pateints with ADRs in subpopulations
Time Frame: Up to 6 months
|
Up to 6 months
|
|
Number of patients with SAEs in supopulations
Time Frame: Up to 6 months
|
Up to 6 months
|
|
Overall survival in subpopulations
Time Frame: Up to 12 months
|
Up to 12 months
|
|
Time to treatment failure (TTF)
Time Frame: Up to 12 months
|
Up to 12 months
|
|
Time to Treatment failure in subpopulations
Time Frame: Up to 12 months
|
Up to 12 months
|
|
Tumor response assessed by RECIST or physicians own evaluation
Time Frame: Up to 6 months
|
RECIST: Response Evaluation Criteria In Solid Tumors
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16472
- STIVARGA-CRC-01 (Other Identifier: company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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