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:||September 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933958
|Contact: Bayer Clinical Trials Contactfirstname.lastname@example.org|
|Many Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|