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

Pfizer logo

Pfizer

Status

Completed

Conditions

Renal Cell Carcinoma

Treatments

Other: Non Interventional

Study type

Observational

Funder types

Industry

Identifiers

NCT00836745
A6181181

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

36 participants in 1 patient group

1
Description:
Non Interventional
Treatment:
Other: Non Interventional

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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