Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program

NCT ID: NCT01412671

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-27

Study Completion Date

2016-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Sorafenib (Nexavar, BAY43-9006)

Intervention Type DRUG

Patients who have received Nexavar for unresectable or advanced RCC.

Interventions

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Sorafenib (Nexavar, BAY43-9006)

Patients who have received Nexavar for unresectable or advanced RCC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion Criteria

* Patients who are contraindicated based on the product label
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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NEXAVAR-RCC-01

Identifier Type: OTHER

Identifier Source: secondary_id

15037

Identifier Type: -

Identifier Source: org_study_id

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