Renal Cancer Clinical Trial
Official title:
Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent
Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.
Status | Completed |
Enrollment | 121 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy Exclusion Criteria: - Hypersensitivity to sunitinib malate or to any of the excipients - Any other contraindication to the use of sunitinib malate (based on decision of the treating physician). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Slovakia | Pfizer Investigational Site | Banska Bystrica | |
Slovakia | Pfizer Investigational Site | Bojnice | |
Slovakia | Pfizer Investigational Site | Bratislava | |
Slovakia | Pfizer Investigational Site | Bratislava | |
Slovakia | Pfizer Investigational Site | Kosice | |
Slovakia | Pfizer Investigational Site | Michalovce | |
Slovakia | Pfizer Investigational Site | Nitra | |
Slovakia | Pfizer Investigational Site | Poprad | |
Slovakia | Pfizer Investigational Site | Presov | |
Slovakia | Pfizer Investigational Site | Ruzomberok | |
Slovakia | Pfizer Investigational Site | Trebisov | |
Slovakia | Pfizer Investigational Site | Trencin | |
Slovakia | Pfizer Investigational Site | Trnava | |
Slovakia | Pfizer Investigational Site | Zilina |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Slovakia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib | 36 months | No | |
Secondary | Dose modifications | 36 months | No | |
Secondary | Incidence of new diagnosed hypertension | 36 months | Yes | |
Secondary | Incidence of new diagnosed hypothyroidism | 36 months | Yes | |
Secondary | Safety of sunitinib malate in "real-life" setting | 36 months | Yes | |
Secondary | Efficacy of sunitinib malate in "real-life" setting | 36 months | No |
Status | Clinical Trial | Phase | |
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