Study In Patients With Kidney Cancer Treated With Sutent

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00873210

Collaborator

(none)

121

Enrollment

Locations

Duration (Months)

8.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced or Metastatic Renal Cell Carcinoma Renal Cancer	Drug: Sutent

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

121 participants

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: sunitinib malate

Arm

Intervention/Treatment

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 Names:

sunitinib malate

Outcome Measures

Primary Outcome Measures

Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib [36 months]

Secondary Outcome Measures

Dose modifications [36 months]
Incidence of new diagnosed hypertension [36 months]
Incidence of new diagnosed hypothyroidism [36 months]
Safety of sunitinib malate in "real-life" setting [36 months]
Efficacy of sunitinib malate in "real-life" setting [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Banska Bystrica	Slovakia	975 17
2	Pfizer Investigational Site	Bojnice	Slovakia	972 01
3	Pfizer Investigational Site	Bratislava	Slovakia	812 50
4	Pfizer Investigational Site	Bratislava	Slovakia	833 10
5	Pfizer Investigational Site	Kosice	Slovakia	043 91
6	Pfizer Investigational Site	Michalovce	Slovakia	071 01
7	Pfizer Investigational Site	Nitra	Slovakia	949 01
8	Pfizer Investigational Site	Poprad	Slovakia	058 01
9	Pfizer Investigational Site	Presov	Slovakia	081 81
10	Pfizer Investigational Site	Ruzomberok	Slovakia	034 26
11	Pfizer Investigational Site	Trebisov	Slovakia	075 01
12	Pfizer Investigational Site	Trencin	Slovakia	911 71
13	Pfizer Investigational Site	Trnava	Slovakia	917 75
14	Pfizer Investigational Site	Zilina	Slovakia	012 07