Study Completed

Carcinoma, Renal Cell

Bayer Identifier:

16268

ClinicalTrials.gov Identifier:

NCT01557127

EudraCT Number:

Not Available

EU CT Number:

Not Available

Nexavar dosing in renal cancer patients in "real-life" setting

Trial purpose

This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Inclusion Criteria
- Age >/= 18 years
- Diagnosis of renal cell carcinoma
- Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2
- Patients in whom the oncologist has decide to start therapy with sorafenib.
Exclusion Criteria
-Synonymous with contraindications to Nexavar.

Trial summary

Enrollment Goal

205

Trial Dates

November 2011 - March 2016

Phase

N/A

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Poland

Primary Outcome

Percentage of patients in whom the actual dose of sorafenib equaled the planned dose
Time Frame:
12 months
Safety Issue:
No

Secondary Outcome

Overall tolerability of treatment as measured by rate of adverse events
Time Frame:
12 months
Safety Issue:
Yes

Trial design

Nexavar dose evaluation study in patients with advanced renal cell carcinoma

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.