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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836745
• Other study ID #: A6181181
• 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

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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

External Links

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