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

NCT00836745

Last updated date
Study Location
Pfizer Investigational Site
New Delhi, Delhi, 110 085, India
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with advanced renal cell cancer

- Treatment naïve or cytokine refractory

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


- Patients presenting with a known hypersensitivity to Sunitinib or its metabolites

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Advanced Information
Descriptive Information
Brief Title Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent
Official Title Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent
Brief Summary 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 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with advanced renal cell cancer in the treatment naïve or cytokine refractory settings prescribed Sutent® will be eligible for the study.
Condition Renal Cell Carcinoma
Intervention Other: Non Interventional
Sutent capsule, once daily administered per the locally approved product information.
Other Name: Observational
Study Groups/Cohorts 1
Non Interventional
Intervention: Other: Non Interventional
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: April 18, 2013)
36
Original Estimated Enrollment
 (submitted: February 3, 2009)
100
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00836745
Other Study ID Numbers A6181181
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 November 2013