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Study In Patients With Kidney Cancer Treated With Sutent

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NCT00873210

Last updated on October 9, 2019
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Banska Bystrica, , 975 17 Slovakia
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced or Metastatic Renal Cell Carcinoma, Renal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00873210
Pfizer
Completed
Study In Patients With Kidney Cancer Treated With Sutent

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Descriptive Information
Brief TitleStudy In Patients With Kidney Cancer Treated With Sutent
Official TitleNon-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent
Brief SummaryObjective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.
Detailed DescriptionConsecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy.
Condition
  • Advanced or Metastatic Renal Cell Carcinoma
  • Renal Cancer
InterventionDrug: Sutent
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause
Other Name: sunitinib malate
Study Groups/CohortsPatients 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: Drug: Sutent
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: December 16, 2011)		121
Original Estimated Enrollment
 (submitted: March 30, 2009)		100
Actual Study Completion DateNovember 2011
Actual Primary Completion DateNovember 2011   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSlovakia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00873210
Other Study ID NumbersA6181185
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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