Gastrointestinal Stromal Tumors
Conditions
Keywords
Regorafenib, Gastrointestinal stromal tumors
Brief summary
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice
Detailed description
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 gastrointestinal stromal tumors progressed after cancer chemotherapy. A total of 135 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months and 24 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
Interventions
DRUGRegorafenib (Stivarga, BAY73-4506)
The usual dosage is 160 mg of Regorafenib/ STIVARGA taken orally after meal once daily for 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib | up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | Up to 3 years | — |
| Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor. | Up to 3 years | Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR) |
| time to treatment failure (TTF) | Up to 3 years | 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. |
| tumour response | Up to 3 years | — |
Countries
Japan
Outcome results
None listed