Trials / Completed
CompletedNCT01728948
Sorafenib in Elderly mRCC
Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib (Nexavar, BAY43-9006) | treatment (including dose, duration, modification) decided by the investigator |
Timeline
- Start date
- 2013-01-06
- Primary completion
- 2016-01-04
- Completion
- 2017-01-16
- First posted
- 2012-11-20
- Last updated
- 2017-11-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01728948. Inclusion in this directory is not an endorsement.