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

NCT ID: NCT00684645

Last Updated: 2012-08-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-04-30

Brief Summary

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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

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180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.

Conditions

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Metastatic Renal Cell Carcinoma

Keywords

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Safety and tolerability of SUTENT® in patients with metastatic or advanced renal cell carcinoma after failure of cytokines in real-life setting.

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients treated with SUTENT®

Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy.

SUTENT

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria

* No previous cytokines therapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brno, , Czechia

Site Status

Pfizer Investigational Site

Brno, , Czechia

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Pfizer Investigational Site

Brno, , Czechia

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Pfizer Investigational Site

Chomutov, , Czechia

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Pfizer Investigational Site

České Budějovice, , Czechia

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Pfizer Investigational Site

Fryštát, , Czechia

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Pfizer Investigational Site

Hradec Králové, , Czechia

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Pfizer Investigational Site

Jihlava, , Czechia

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Pfizer Investigational Site

Liberec, , Czechia

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Pfizer Investigational Site

Nová Ves pod Pleší, , Czechia

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Pfizer Investigational Site

Nový Jičín, , Czechia

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Pfizer Investigational Site

Ostrava, , Czechia

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Pfizer Investigational Site

Ostrava, , Czechia

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Pfizer Investigational Site

Pardubice, , Czechia

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Pfizer Investigational Site

Pilsen, , Czechia

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Pfizer Investigational Site

Prague, , Czechia

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Pfizer Investigational Site

Prague, , Czechia

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Pfizer Investigational Site

Prague, , Czechia

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Pfizer Investigational Site

Prague, , Czechia

Site Status

Pfizer Investigational Site

Zlín, , Czechia

Site Status

Countries

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Czechia

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181171&StudyName=Non-Interventional%20Study%20%28NIS%29%20In%20Patients%20With%20Advanced%20And/Or%20Metastatic%20Renal%20Cell%20Carcinoma%20%28mRCC%29%20Treated%20With%20SUTENT%AE

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6181171

Identifier Type: -

Identifier Source: org_study_id