Regorafenib Post-marketing Surveillance in Japan
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01933958|
Recruitment Status : Recruiting
First Posted : September 2, 2013
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment|
|Gastrointestinal Stromal Tumors||Drug: Regorafenib (Stivarga, BAY73-4506)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||135 participants|
|Official Title:||Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy|
|Actual Study Start Date :||September 4, 2013|
|Estimated Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||January 30, 2021|
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.
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib. [ Time Frame: Up to 6 months ]
- Number of patients with serious adverse events(SAEs) from the first administration of regorafenib. [ Time Frame: Up to 6 months ]
- Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib [ Time Frame: up to 6 months ]
- overall survival (OS) [ Time Frame: Up to 3 years ]
- time to treatment failure (TTF) [ Time Frame: 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 [ Time Frame: Up to 3 years ]
- Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor. [ Time Frame: 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933958
|Contact: Bayer Clinical Trials Contact||49 30 email@example.com|
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|