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NCT00873210 Clinical Trial

Study In Patients With Kidney Cancer Treated With Sutent

Renal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00873210
Other study ID # A6181185
Secondary ID
Status Completed
Phase N/A
First received March 30, 2009
Last updated November 7, 2012
Start date May 2009
Est. completion date November 2011

Study information
Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Slovakia: Ethics Commitee of the Bratislava Selgf-Governing Region
Study type Observational

Clinical Trial Summary

Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.

Description:

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

Recruitment information / eligibility
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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Sutent
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Slovakia, 

Outcome
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
See also
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Completed NCT00418496 - Interleukin-2 With Sorafenib (BAY 43-9006) for Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma Phase 1

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