Trial Condition(s):
Carcinoma, Renal Cell
Sorafenib in elderly mRCC
Bayer Identifier:
16399
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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%.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Non-interventional Study of effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) treated with Sorafenib
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Overall survivalTimeframe: up to 2.5 years
Secondary Outcome
- Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) CriteriaTimeframe: up to 2.5 years
- Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) CriteriaTimeframe: up to 2.5 years
- Survival rate by one yearTimeframe: up to 1 year
- Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerabilityTimeframe: up to 3.5 years
- Patient characteristics (birthdate (at least year), sex, weight, height, etc)Timeframe: up to 2.5 years
- Response rate (RR)Timeframe: up to 3.5 years
- Time to first relief of clinical symptoms and physical signsTimeframe: up to 3.5 years
- Treatment patternTimeframe: up to 3.5 years
Additional Information
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