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


Phase 4
18 Years
75 Years
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

India: Drugs Controller General of India

Study ID:

A6181181

NCT ID:

NCT00836745

Start Date:

March 2009

Completion Date:

July 2012

Related Keywords:

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

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