check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

16399

ClinicalTrials.gov Identifier:

NCT01728948

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sorafenib in elderly mRCC

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%.

Key Participants Requirements

Sex

Both

Age

65 - N/A
  • - 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
  • - The approved local product label must be followed for the exclusion criteria

Trial summary

Enrollment Goal
60
Trial Dates
January 2013 - January 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, China

Primary Outcome

  • Overall survival
    date_rangeTime Frame:
    up to 2.5 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
    date_rangeTime Frame:
    up to 2.5 years
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    Safety Issue:
    No
  • Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria
    date_rangeTime Frame:
    up to 2.5 years
    enhanced_encryption
    Safety Issue:
    No
  • Survival rate by one year
    date_rangeTime Frame:
    up to 1 year
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    Safety Issue:
    No
  • Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability
    date_rangeTime Frame:
    up to 3.5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Patient characteristics (birthdate (at least year), sex, weight, height, etc)
    date_rangeTime Frame:
    up to 2.5 years
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    Safety Issue:
    No
  • Response rate (RR)
    date_rangeTime Frame:
    up to 3.5 years
  • Time to first relief of clinical symptoms and physical signs
    date_rangeTime Frame:
    up to 3.5 years
  • Treatment pattern
    date_rangeTime Frame:
    up to 3.5 years

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
N/A

Additional Information

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