Study In Patients With Kidney Cancer Treated With Sutent
Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent
1 other identifier
observational
121
1 country
14
Brief Summary
Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2009
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2009
CompletedFirst Posted
Study publicly available on registry
April 1, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedNovember 9, 2012
November 1, 2012
2.5 years
March 30, 2009
November 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib
36 months
Secondary Outcomes (5)
Dose modifications
36 months
Incidence of new diagnosed hypertension
36 months
Incidence of new diagnosed hypothyroidism
36 months
Safety of sunitinib malate in "real-life" setting
36 months
Efficacy of sunitinib malate in "real-life" setting
36 months
Study Arms (1)
Patients treated with Sutent
125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Interventions
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause
Eligibility Criteria
Patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy.
You may qualify if:
- Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (14)
Pfizer Investigational Site
Banská Bystrica, 975 17, Slovakia
Pfizer Investigational Site
Bojnice, 972 01, Slovakia
Pfizer Investigational Site
Bratislava, 812 50, Slovakia
Pfizer Investigational Site
Bratislava, 833 10, Slovakia
Pfizer Investigational Site
Košice, 043 91, Slovakia
Pfizer Investigational Site
Michalovce, 071 01, Slovakia
Pfizer Investigational Site
Nitra, 949 01, Slovakia
Pfizer Investigational Site
Poprad, 058 01, Slovakia
Pfizer Investigational Site
Prešov, 081 81, Slovakia
Pfizer Investigational Site
Ružomberok, 034 26, Slovakia
Pfizer Investigational Site
Trebišov, 075 01, Slovakia
Pfizer Investigational Site
Trenčín, 911 71, Slovakia
Pfizer Investigational Site
Trnava, 917 75, Slovakia
Pfizer Investigational Site
Žilina, 012 07, Slovakia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2009
First Posted
April 1, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
November 9, 2012
Record last verified: 2012-11