Trial Condition(s):
Carcinoma, Renal Cell
Study to observe safety and efficacy of Nexavar in treatment of kidney cancer (POWER-NEXT)
Bayer Identifier:
15246
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The objective of this Non-Interventional study is to evaluate the effectiveness & safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age >70 years) and younger patients (age <70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.
Inclusion Criteria
- Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib
Exclusion Criteria
- Exclusion criteria must be read in conjunction with the local product information.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
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Trial Design
Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Efficacy related variables are status of tumor / metastases.Timeframe: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
- Efficacy related variables are patient's performance status.Timeframe: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
- Efficacy related variables are efficacy assessment by the physician.Timeframe: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
- Efficacy related variable - Quality of Life (QOL) assessment by the patientTimeframe: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Secondary Outcome
- General tolerability assessment by physician and reports of adverse events.Timeframe: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Additional Information
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