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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00836745
Other study ID # A6181181
Secondary ID
Status Completed
Phase N/A
First received February 2, 2009
Last updated November 26, 2013
Start date March 2009
Est. completion date July 2012

Study information

Verified date November 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority India: Drugs Controller General of India
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Non Interventional
Sutent capsule, once daily administered per the locally approved product information.

Locations

Country Name City State
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Chandigard Punjab
India Pfizer Investigational Site Delhi
India Pfizer Investigational Site Jaipur
India Pfizer Investigational Site Kolkata West Bengal
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose) No
Secondary Percentage of Participants With Objective Response (OR) Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose) No
Secondary Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented. Baseline up to 1 year from start of first dose Yes
Secondary Number of Participants Who Required Management of Other Adverse Events An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented. Baseline up to 1 year from start of first dose Yes
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