- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01412671
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
June 4, 2018 updated by: Bayer
Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma: Early Access Program)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
117
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Multiple Locations, Japan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The target population of this study is patients who received Nexavar for unresectable or advanced RCC.
Description
Inclusion Criteria:
- Patients who received Nexavar for unresectable or advanced renal cell carcinoma
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
|
Patients who have received Nexavar for unresectable or advanced RCC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
Time Frame: After Nexavar administration, up to 1 year
|
After Nexavar administration, up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)]
Time Frame: After Nexavar administration, up to 1 year
|
After Nexavar administration, up to 1 year
|
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]
Time Frame: After Nexavar administration, up to 1 year
|
After Nexavar administration, up to 1 year
|
The status of therapy with Nexavar [duration of treatment, daily dose]
Time Frame: After Nexavar administration, up to 1 year
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After Nexavar administration, up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2008
Primary Completion (Actual)
September 21, 2011
Study Completion (Actual)
February 28, 2016
Study Registration Dates
First Submitted
August 7, 2011
First Submitted That Met QC Criteria
August 7, 2011
First Posted (Estimate)
August 9, 2011
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- 15037
- NEXAVAR-RCC-01 (Other Identifier: Company Internal)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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