check_circleStudy Completed
Carcinoma, Renal Cell
Bayer Identifier:
15038
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Nexavar post-marketing surveillance for renal cell carcinoma in Japan
Trial purpose
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
3305Trial Dates
April 2008 - February 2016Phase
N/ACould I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavardate_rangeTime Frame:After Nexavar administration, up to 1 yearenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]date_rangeTime Frame:After Nexavar administration, up to 1 yearenhanced_encryptionYesSafety Issue:
- Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]date_rangeTime Frame:After Nexavar administration, up to 1 yearenhanced_encryptionNoSafety Issue:
- The status of therapy with Nexavar [duration of treatment, daily dose]date_rangeTime Frame:After Nexavar administration, up to 1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A