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: November 26, 2013
Last verified: November 2013
  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
Renal Cell Carcinoma
Other: Non Interventional

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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events [ Time Frame: Baseline up to 1 year from start of first dose ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants Who Required Management of Other Adverse Events [ Time Frame: Baseline up to 1 year from start of first dose ] [ Designated as safety issue: Yes ]
    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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00836745     History of Changes
Other Study ID Numbers: A6181181
Study First Received: February 2, 2009
Results First Received: July 29, 2013
Last Updated: November 26, 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 August 28, 2014