Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
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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.
| Condition | Intervention |
|---|---|
|
Carcinoma, Renal Cell |
Drug: Sorafenib (Nexavar, BAY43-9006) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma: Early Access Program) |
- Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as 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] [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as safety issue: No ]
- The status of therapy with Nexavar [duration of treatment, daily dose] [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 117 |
| Study Start Date: | February 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable or advanced RCC.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The target population of this study is patients who received Nexavar for unresectable or advanced RCC.
Inclusion Criteria:
- Patients who received Nexavar for unresectable or advanced renal cell carcinoma
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head Medical Development Japan, Bayer Yakuhin, Ltd. |
| ClinicalTrials.gov Identifier: | NCT01412671 History of Changes |
| Other Study ID Numbers: | 15037, NEXAVAR-RCC-01 |
| Study First Received: | August 7, 2011 |
| Last Updated: | April 10, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Bayer:
|
Nexavar unresectable or advanced renal cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013