Trials / Completed
CompletedNCT01412671
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma: Early Access Program)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 117 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib (Nexavar, BAY43-9006) | Patients who have received Nexavar for unresectable or advanced RCC. |
Timeline
- Start date
- 2008-02-27
- Primary completion
- 2011-09-21
- Completion
- 2016-02-28
- First posted
- 2011-08-09
- Last updated
- 2018-06-06
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01412671. Inclusion in this directory is not an endorsement.