Trial Condition(s):
Gastrointestinal stromal tumors
Regorafenib post-marketing surveillance in Japan
Bayer Identifier:
16732
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice
Inclusion Criteria
- Patients who are treated with Regorafenib/ STIVARGA and meet the product label.
Exclusion Criteria
- Patients who are treated with Regorafenib/ STIVARGA and don’t meet the product label.
Trial Summary
Enrollment Goal
72
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Drug Use Investigation of Regorafenib/ STIVARGA for gastrointestinal stromal tumor progressed after cancer chemotherapy
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 regorafenib.Timeframe: Up to 6 months
- Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.Timeframe: Up to 6 months
- Number of Patients with serious adverse drug reactions (SADRs) from the first administration of RegorafenibTimeframe: up to 6 months
Secondary Outcome
- overall survival (OS)Timeframe: Up to 3 years
- time to treatment failure (TTF)TTF is defined as the time interval from start of Regorafenib/ STIVARGA therapy to the date of permanent discontinuation for any reason including disease progression, adverse event, patient preference or death.Timeframe: Up to 3 years
- tumour responseTimeframe: Up to 3 years
- Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR)Timeframe: Up to 3 years
Additional Information
Not Available
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