Sorafenib in Elderly mRCC

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

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%.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Renal Cell
• Intervention / Treatment: Drug: Sorafenib (Nexavar, BAY43-9006)

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Many Locations, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

mRCC patients, >= 65 years of age, No prior systemic treatment, need systemic therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Sorafenib (Nexavar, BAY43-9006); treatment (including dose, duration, modification) decided by the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	up to 2.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2013
• Primary Completion (Actual): January 4, 2016
• Study Completion (Actual): January 16, 2017

Study Registration Dates

• First Submitted: November 14, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Sorafenib; safety; elderly; effectiveness; renal cell carcinoma(RCC)
• 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: 16399; NX1212CN (Other Identifier: company internal)