Regorafenib Post-marketing Surveillance
Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer
2 other identifiers
observational
1,301
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2013
CompletedFirst Submitted
Initial submission to the registry
April 26, 2013
CompletedFirst Posted
Study publicly available on registry
April 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2016
CompletedAugust 2, 2018
July 1, 2018
3.4 years
April 26, 2013
August 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
up to 6 months
Secondary Outcomes (7)
Number of pateints with ADRs in subpopulations
Up to 6 months
Number of patients with SAEs in supopulations
Up to 6 months
Overall survival (OS)
Up to 12 months
Overall survival in subpopulations
Up to 12 months
Time to treatment failure (TTF)
Up to 12 months
- +2 more secondary outcomes
Study Arms (1)
Group 1
Interventions
Patients treated with Regorafenib under practical manner for colorectal cancer.
Eligibility Criteria
Patients with unresectable, metastatic or recurrent colorectal cancer
You may qualify if:
- who are determined to start Regorafenib/ STIVARGA treatment
You may not qualify if:
- Patients who have previously received Regorafenib/ STIVARGA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Multiple Locations, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2013
First Posted
April 30, 2013
Study Start
April 22, 2013
Primary Completion
September 12, 2016
Study Completion
November 14, 2016
Last Updated
August 2, 2018
Record last verified: 2018-07