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Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent

NCT ID: NCT00836745

Last Updated: 2013-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-07-31

Brief Summary

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The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.

Detailed Description

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The assignment of the patient to Sutent® treatment is not decided in advance by this noninterventional study protocol, but falls within current practice. The decision to prescribe Sutent® is clearly not driven by the decision to include the patient in this study.The sample size for this study is not based on statistical considerations. It is expected that a minimum of 100 patients will be enrolled in the study by the end of the first year and the data collected would be adequate to fulfill the observational objectives of the study.The study will be initiated at 10 sites across India during the 1st year. The study may be expanded with the addition of new sites during the 2nd year.

Conditions

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Renal Cell Carcinoma

Keywords

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Advanced renal cell Cancer Non interventional study Renal Cancer Sutent Metastatic Advanced Renal Cell Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Non Interventional

Non Interventional

Intervention Type OTHER

Sutent capsule, once daily administered per the locally approved product information.

Interventions

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Non Interventional

Sutent capsule, once daily administered per the locally approved product information.

Intervention Type OTHER

Other Intervention Names

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Observational

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced renal cell cancer
* Treatment naïve or cytokine refractory

Exclusion Criteria

* Patients presenting with a known hypersensitivity to Sunitinib or its metabolites
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Jaipur, Jaipur, India

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Mumbai, Maharashtra, India

Site Status

Pfizer Investigational Site

New Delhi, National Capital Territory of Delhi, India

Site Status

Pfizer Investigational Site

Chandigard, Punjab, India

Site Status

Pfizer Investigational Site

Kolkata, West Bengal, India

Site Status

Pfizer Investigational Site

Delhi, , India

Site Status

Countries

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India

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181181&StudyName=Non-Interventional%20Study%20Of%20Indian%20Patients%20With%20Advanced%20Renal%20Cell%20Cancer%20Receiving%20Therapy%20With%20Sutent

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

Other Identifiers

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A6181181

Identifier Type: -

Identifier Source: org_study_id