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

NCT00836745 | Completed Results

• 1 other identifier: A6181181
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 7

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.

Conditions

Renal Cell Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Percentage of Participants With Objective Response (OR)

  Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)

• Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events

  Baseline up to 1 year from start of first dose

• Number of Participants Who Required Management of Other Adverse Events

  Baseline up to 1 year from start of first dose

Study Arms (1)

1

Non Interventional

Other: Non Interventional

Interventions

Non Interventional OTHER

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

Also known as: Observational

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Pfizer Investigational Site

Jaipur, Jaipur, 302006, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 027, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400014, India

Location

Pfizer Investigational Site

New Delhi, National Capital Territory of Delhi, 110 085, India

Location

Pfizer Investigational Site

Chandigard, Punjab, 141402, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 700 106, India

Location

Pfizer Investigational Site

Delhi, 110 060, India

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Neoplasm Metastasis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Limitations and Caveats

Relatively small sample size might limit any useful interpretation and applicability of data for larger populations.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 20, 2013
• Results First Posted: December 20, 2013

Record last verified: 2013-11

Locations

IN (7)