Trial Condition(s):

Carcinoma, Renal Cell

Sorafenib as neoadjuvant therapy before cytoreductive nephrectomy in patients with metastatic renal cell carcinoma (SANE)

Bayer Identifier:

16933

ClinicalTrials.gov Identifier:

NCT01982097

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This local, prospective, multicenter, non-interventional study documents observational data on patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from Nexavar before cytoreductive nephrectomy.

Inclusion Criteria
-  - Male and female patients ≥ 18 years old 
 - Patients with untreated metastatic RCC in whom a decision on neoadjuvant treatment with Nexavar before cytoreductive nephrectomy and in case of clinical feasibility resumption of treatment with Nexavar after nephrectomy has been made at the time of study enrollment
 - Life expectancy of at least 16 weeks
 - Patients should have signed informed consent form
Exclusion Criteria
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
 - All contra-indications according to the Russian marketing authorization:
 -- Hypersensitivity to sorafenib or to any of the excipients. 
 -- Pregnancy and breast-feeding.
 -- Age less than 18 years.

Trial Summary

Enrollment Goal
61
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 

Trial Design