Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

NCT ID: NCT01411423

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

3305 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-18

Study Completion Date

2016-02-28

Brief Summary

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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.

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

References

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Inamoto T, Azuma H, Tatsugami K, Oya M, Adachi M, Okayama Y, Sunaya T, Akaza H. Real-world use of sorafenib for advanced renal cell carcinoma patients with cardiovascular disease: nationwide survey in Japan. Expert Rev Anticancer Ther. 2020 Jul;20(7):615-623. doi: 10.1080/14737140.2020.1773805. Epub 2020 Jun 16.

Reference Type DERIVED
PMID: 32441582 (View on PubMed)

Other Identifiers

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NEXAVAR-RCC-02

Identifier Type: OTHER

Identifier Source: secondary_id

15038

Identifier Type: -

Identifier Source: org_study_id

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