check_circleStudy 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
  • - 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.
  • -Synonymous with contraindications to Nexavar.

Trial summary

Enrollment Goal
205
Trial Dates
November 2011 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

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

Secondary Outcome

  • Overall tolerability of treatment as measured by rate of adverse events
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    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

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