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SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- First-line treatment in patients with metastatic renal cell carcinoma

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

NCT00460798
Pfizer
Completed
SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

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Descriptive Information
Brief TitleSUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Official TitleA Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer
Brief Summary

This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be

1 year.

Detailed DescriptionThe Statistical Analysis Plan provides detailed specification of the analysis
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients treated by office-based oncologists, office-based urologists specialized in oncology or hospital-based oncologist/urologists
ConditionRenal Cell Carcinoma
InterventionOther: Sutent: observational study
SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Other Name: sunitinib malate
Study Groups/CohortsNon-Interventional Study
Intervention: Other: Sutent: observational study
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: November 3, 2010)
356
Original Enrollment
 (submitted: April 13, 2007)
600
Actual Study Completion DateSeptember 2009
Actual Primary Completion DateSeptember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • First-line treatment in patients with metastatic renal cell carcinoma

Exclusion Criteria:

  • Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00460798
Other Study ID NumbersA6181115
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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