Regorafenib Post-marketing Surveillance in Japan
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy|
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib. [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
- Number of patients with serious adverse events(SAEs) from the first administration of regorafenib. [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
- Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
- overall survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- time to treatment failure (TTF) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR)
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy.
Drug: Regorafenib (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.
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.
|Contact: Bayer Clinical Trials Contactfirstname.lastname@example.org|
|Many Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|