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SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

NCT ID: NCT00460798

Last Updated: 2010-11-16

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

356 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-09-30

Brief Summary

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This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be

1 year.

Detailed Description

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The Statistical Analysis Plan provides detailed specification of the analysis

Conditions

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Renal Cell Carcinoma

Keywords

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Sunitinib kidney diseases urogenital neoplasms kidney cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-Interventional Study

Sutent: observational study

Intervention Type OTHER

SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Interventions

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Sutent: observational study

SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Intervention Type OTHER

Other Intervention Names

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sunitinib malate

Eligibility Criteria

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Inclusion Criteria

* First-line treatment in patients with metastatic renal cell carcinoma

Exclusion Criteria

* Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181115&StudyName=SUTENT%AE%20In%20The%20First%20Line%20Treatment%20Of%20Renal%20Cell%20Carcinoma%20

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

Other Identifiers

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A6181115

Identifier Type: -

Identifier Source: org_study_id