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

NCT01412671 | Completed

• 2 other identifiers: 15037NEXAVAR-RCC-01
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Renal Cell

Keywords

Nexavar; unresectable or advanced renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar

  After Nexavar administration, up to 1 year

Secondary Outcomes (3)

• 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)]

  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]

  After Nexavar administration, up to 1 year

• The status of therapy with Nexavar [duration of treatment, daily dose]

  After Nexavar administration, up to 1 year

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Patients who have received Nexavar for unresectable or advanced RCC.

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population of this study is patients who received Nexavar for unresectable or advanced RCC.

You may qualify if:

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

You may not qualify if:

• Patients who are contraindicated based on the product label

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2011
• First Posted: August 9, 2011
• Study Start: February 27, 2008
• Primary Completion: September 21, 2011
• Study Completion: February 28, 2016
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

JP (1)