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

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brno, , 625 00 Czech Republic
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma
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

- Patients with advanced or metastatic renal cell carcinoma.

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

- No previous cytokines therapy.

NCT00684645
Pfizer
Completed
Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

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Descriptive Information
Brief TitleNon-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Official TitleNon-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Brief SummaryPrimary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.
Detailed Description180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy.
ConditionMetastatic Renal Cell Carcinoma
InterventionDrug: SUTENT
SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity.
Study Groups/CohortsPatients treated with SUTENT®
Patients with metastatic or advanced renal cell carcinoma after failure of cytokines 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: June 9, 2011)
186
Original Estimated Enrollment
 (submitted: May 22, 2008)
180
Actual Study Completion DateApril 2011
Actual Primary Completion DateApril 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

  • No previous cytokines therapy.
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 CountriesCzech Republic
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00684645
Other Study ID NumbersA6181171
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 DateJuly 2012

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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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