Sorafenib in Elderly mRCC

Carcinoma, Renal Cell Clinical Trial

Official title:

Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728948
• Other study ID #: 16399
• Secondary ID: NX1212CN
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: November 8, 2017
• Start date: January 6, 2013
• Est. completion date: January 16, 2017

Study information

• Verified date: November 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 16, 2017
• Est. primary completion date: January 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.

• >=65 years of age

• Patients who have signed the informed consent

• Patients with a life expectancy of =12 weeks

• No prior systemic treatment

Exclusion Criteria:

• The approved local product label must be followed for the exclusion criteria

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
treatment (including dose, duration, modification) decided by the investigator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		up to 2.5 years
Secondary	Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria		up to 2.5 years
Secondary	Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria		up to 2.5 years
Secondary	Survival rate by one year		up to 1 year
Secondary	Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability		up to 3.5 years
Secondary	Patient characteristics (birthdate (at least year), sex, weight, height, etc)		up to 2.5 years
Secondary	Response rate (RR)		up to 3.5 years
Secondary	Time to first relief of clinical symptoms and physical signs		up to 3.5 years
Secondary	Treatment pattern		up to 3.5 years

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