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Completed

NCT Number: NCT00873210

Study In Patients With Kidney Cancer Treated With Sutent

Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.

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Key information

Conditions

Advanced or Metastatic Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Banská Bystrica, Slovakia

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About this study

Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy

Exclusion criteria

  • Hypersensitivity to sunitinib malate or to any of the excipients
  • Any other contraindication to the use of sunitinib malate (based on decision of the treating physician).

Treatment and study plan

Sutent

Drug

50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause

Other names: sunitinib malate

Primary outcomes

  1. Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib

    Time frame: 36 months

Secondary outcomes

  1. Dose modifications

    Time frame: 36 months

  2. Incidence of new diagnosed hypertension

    Time frame: 36 months

  3. Incidence of new diagnosed hypothyroidism

    Time frame: 36 months

  4. Safety of sunitinib malate in "real-life" setting

    Time frame: 36 months

  5. Efficacy of sunitinib malate in "real-life" setting

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 1, 2009
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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