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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00836745
First received: February 2, 2009
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
 Other: Non Interventional
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Objective response rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Management of skin and subcutaneous tissue related adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Management of all other adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Non Interventional
 Other: Non Interventional
Sutent capsule, once daily administered per the locally approved product information.
Other Name: Observational

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.

  Eligibility

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836745

Locations
India
Pfizer Investigational Site
New Delhi, Delhi, India, 110 085
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 027
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400014
Pfizer Investigational Site
Chandigard, Punjab, India, 141402
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 106
Pfizer Investigational Site
Delhi, India, 110 060
Pfizer Investigational Site
Jaipur, India, 302006
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00836745     History of Changes
Other Study ID Numbers: A6181181
Study First Received: February 2, 2009
Last Updated: April 18, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Pfizer:
Advanced renal cell Cancer
Non interventional study
Renal Cancer
 Sutent
Metastatic
Advanced Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013