check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

15038

ClinicalTrials.gov Identifier:

NCT01411423

EudraCT Number:

Not Available

EU CT Number:

Not Available
Nexavar post-marketing surveillance for renal cell carcinoma in Japan

Trial purpose

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who received Nexavar for unresectable or advanced renal cell carcinoma

  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
3305
Trial Dates
April 2008 - February 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, Japan

Primary Outcome

  • Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
    date_rangeTime Frame:
    After Nexavar administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]
    date_rangeTime Frame:
    After Nexavar administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    Yes
  • Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]
    date_rangeTime Frame:
    After Nexavar administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • The status of therapy with Nexavar [duration of treatment, daily dose]
    date_rangeTime Frame:
    After Nexavar administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    No

Trial design

Special drug use investigation of Nexavar (unresectable or 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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