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

Phase 4

Completed

• Conditions: Advanced Renal Cell Carcinoma

• Registration Number: CTRI/2009/091/000348
• Lead Sponsor: Pfizer

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.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Prospective, multi-center, non-interventional, non-comparative (single arm) study.

As of 23 November 2012, 38 subjects have been enrolled  in this study. The recruitment is stopped in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-21
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

• Ages Eligible for Study: 18 Years to 75 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No 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.
• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	1 year

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	1 year
Management of all other adverse events	1 year
Objective response rate	1 year
Management of skin & subcutaneous tissue related adverse events	1 year

Trial Locations

Locations (9)

Bangalore Institute of Oncology; 🇮🇳 Bangalore, KARNATAKA, India

BND Oncology center, Dr.Ambedkar Road; 🇮🇳 Mumbai, MAHARASHTRA, India

Delwin Hospital; 🇮🇳 Gurdaspur, PUNJAB, India

Dr. Lalit Mohans Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Jaslok Hospital & Research Center; 🇮🇳 Mumbai, MAHARASHTRA, India

Lakeshore Hospital & Research Centre Ltd; 🇮🇳 Nettoor,-682, India

Rajiv Gandhi Cancer Hospital & Research Institute; 🇮🇳 Delhi, DELHI, India

Sir Gangaram Hospital; 🇮🇳 Delhi, DELHI, India

Subodh Mitra Cancer Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Bangalore Institute of Oncology

🇮🇳Bangalore, KARNATAKA, India

Dr Shekhar Patil

Principal investigator

09829060128

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