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

NCT00684645

Last updated date
Study Location
Pfizer Investigational Site
Brno, , 625 00, Czech Republic
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Official Title Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Brief Summary Primary 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 Description 180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy.
Condition Metastatic Renal Cell Carcinoma
Intervention Drug: 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/Cohorts Patients 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 Status Completed
Actual Enrollment
 (submitted: June 9, 2011)
186
Original Estimated Enrollment
 (submitted: May 22, 2008)
180
Actual Study Completion Date April 2011
Actual Primary Completion Date April 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number NCT00684645
Other Study ID Numbers A6181171
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2012