check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

15037

ClinicalTrials.gov Identifier:

NCT01412671

EudraCT Number:

Not Available

EU CT Number:

Not Available
Nexavar post-marketing surveillance for RCC in Japan: Early access program

Trial purpose

This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.

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
117
Trial Dates
February 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, clinical staging of RCC, 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: Early access program)
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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