Study In Patients With Kidney Cancer Treated With Sutent

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00873210
First received: March 30, 2009
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Advanced or Metastatic Renal Cell Carcinoma
Renal Cancer
Drug: Sutent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose modifications [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of new diagnosed hypertension [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Incidence of new diagnosed hypothyroidism [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Safety of sunitinib malate in "real-life" setting [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Efficacy of sunitinib malate in "real-life" setting [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: May 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients treated with Sutent
125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Drug: Sutent
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause
Other Name: sunitinib malate

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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).
  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: NCT00873210

Locations
Slovakia
Pfizer Investigational Site
Banska Bystrica, Slovakia, 975 17
Pfizer Investigational Site
Bojnice, Slovakia, 972 01
Pfizer Investigational Site
Bratislava, Slovakia, 812 50
Pfizer Investigational Site
Bratislava, Slovakia, 833 10
Pfizer Investigational Site
Kosice, Slovakia, 043 91
Pfizer Investigational Site
Michalovce, Slovakia, 071 01
Pfizer Investigational Site
Nitra, Slovakia, 949 01
Pfizer Investigational Site
Poprad, Slovakia, 058 01
Pfizer Investigational Site
Presov, Slovakia, 081 81
Pfizer Investigational Site
Ruzomberok, Slovakia, 034 26
Pfizer Investigational Site
Trebisov, Slovakia, 075 01
Pfizer Investigational Site
Trencin, Slovakia, 911 71
Pfizer Investigational Site
Trnava, Slovakia, 917 75
Pfizer Investigational Site
Zilina, Slovakia, 012 07
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: NCT00873210     History of Changes
Other Study ID Numbers: A6181185
Study First Received: March 30, 2009
Last Updated: November 7, 2012
Health Authority: Slovakia: Ethics Commitee of the Bratislava Selgf-Governing Region

Keywords provided by Pfizer:
renal cell carcinoma
sunitinib malate

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
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