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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Keimyung University Dongsan Medical Center
Jung-gu, Daegu, 100-712 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Stromal Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients diagnosed as gastrointestinal stromal tumor (GIST) after disease progression
on or intolerance to imatinib mesylate, or advanced renal cell carcinoma (aRCC) will
be included in the study, or patients diagnosed as unresectable, well-differentiated
advanced and/or metastatic pancreatic neuroendocrine carcinoma.

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

- Any patient who does not agree that Pfizer and companies working with Pfizer use
his/her information will be excluded.

- Patients with hypersensitivity to sunitinib malate or to any other component of
Sutent

NCT00444795
Pfizer
Completed
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

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Descriptive Information
Brief TitlePost Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Official TitlePost Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Brief SummaryTo monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)
Detailed DescriptionAll the patients prescribed according to approved indications at contracted institutions
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationpatients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate or patients diagnosed as advanced RCC or patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma
ConditionGastrointestinal Stromal Tumors
Intervention
  • Drug: Sunitinib malate
    Sunitinib : dosing not pre-determined
  • Drug: sunitinib malate
    Sunitinib : dosing not pre-determined
Study Groups/Cohorts
  • 1
    patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate
    Intervention: Drug: Sunitinib malate
  • 2
    patients diagnosed as advanced RCC
    Intervention: Drug: Sunitinib malate
  • 3
    patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma
    Intervention: Drug: sunitinib malate
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: March 23, 2016)
520
Original Enrollment
 (submitted: March 7, 2007)
3000
Actual Study Completion DateMarch 2015
Actual Primary Completion DateMarch 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed as gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, or advanced renal cell carcinoma (aRCC) will be included in the study, or patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma.

Exclusion Criteria:

  • Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information will be excluded.
  • Patients with hypersensitivity to sunitinib malate or to any other component of Sutent
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00444795
Other Study ID NumbersA6181146
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2016

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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