Trial Condition(s):
Carcinoma, Renal Cell
Nexavar post-marketing surveillance for RCC in Japan: Early access program
Bayer Identifier:
15037
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients who received Nexavar for unresectable or advanced renal cell carcinoma
Exclusion Criteria
- Patients who are contraindicated based on the product label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Special drug use investigation of Nexavar (unresectable or advanced renal cell carcinoma: Early access program)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subjects who received NexavarTimeframe: After Nexavar administration, up to 1 year
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)]Timeframe: After Nexavar administration, up to 1 year
- 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]Timeframe: After Nexavar administration, up to 1 year
- The status of therapy with Nexavar [duration of treatment, daily dose]Timeframe: After Nexavar administration, up to 1 year
Additional Information
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