check_circleStudy Completed
Carcinoma, Renal Cell
Bayer Identifier:
15037
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Nexavar post-marketing surveillance for RCC in Japan: Early access program
Trial purpose
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
117Trial Dates
February 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, clinical staging of RCC, 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