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Clinical Trials/NCT00873210
NCT00873210
Completed
Not Applicable

Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent

Pfizer1 site in 1 country121 target enrollmentMay 2009

Overview

Phase
Not Applicable
Intervention
Sutent
Conditions
Advanced or Metastatic Renal Cell Carcinoma
Sponsor
Pfizer
Enrollment
121
Locations
1
Primary Endpoint
Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib
Status
Completed
Last Updated
13 years ago

Overview

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.

Detailed Description

Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
November 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

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).

Arms & Interventions

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

Intervention: Sutent

Outcomes

Primary Outcomes

Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib

Time Frame: 36 months

Secondary Outcomes

  • 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 Sites (1)

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