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CompletedNCT00873210Updated Nov 9, 2012

Study In Patients With Kidney Cancer Treated With Sutent

An observational study in Advanced or Metastatic Renal Cell Carcinoma and Renal Cancer, sponsored by Pfizer. Completed at 14 sites in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-09.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
121
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

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Conditions studied

  • Advanced or Metastatic Renal Cell Carcinoma
  • Renal Cancer

Keywords

  • renal cell carcinoma
  • sunitinib malate
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 121 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
121 participants (actual)

Groups and cohorts

  • 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

    Drug: Sutent

Interventions

  • DrugSutent

    50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause

    Also known as: sunitinib malate

06

What researchers measure

Primary outcomes

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

    Time frame: 36 months

Secondary outcomes

  1. Dose modifications

    Time frame: 36 months

  2. Incidence of new diagnosed hypertension

    Time frame: 36 months

  3. Incidence of new diagnosed hypothyroidism

    Time frame: 36 months

  4. Safety of sunitinib malate in "real-life" setting

    Time frame: 36 months

  5. Efficacy of sunitinib malate in "real-life" setting

    Time frame: 36 months

07

Study locations

14 sites
  • Pfizer Investigational Site
    Banska 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
    Kosice, 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
    Presov, 081 81, Slovakia
  • Pfizer Investigational Site
    Ruzomberok, 034 26, Slovakia
  • Pfizer Investigational Site
    Trebisov, 075 01, Slovakia
  • Pfizer Investigational Site
    Trencin, 911 71, Slovakia
  • Pfizer Investigational Site
    Trnava, 917 75, Slovakia
  • Pfizer Investigational Site
    Zilina, 012 07, Slovakia
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00873210
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Apr 1, 2009
Start date
May 2009
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Nov 9, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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