Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

NCT00444795

Last updated date
Study Location
Keimyung University Dongsan Medical Center
Jung-gu, Daegu, 100-712, Korea, Republic of
Contact
1-800-718-1021

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1-800-718-1021

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[email protected]

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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

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Advanced Information
Descriptive Information
Brief Title Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Official Title Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Brief Summary To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)
Detailed Description All the patients prescribed according to approved indications at contracted institutions
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients 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
Condition Gastrointestinal 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 Status Completed
Actual Enrollment
 (submitted: March 23, 2016)
520
Original Enrollment
 (submitted: March 7, 2007)
3000
Actual Study Completion Date March 2015
Actual Primary Completion Date March 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00444795
Other Study ID Numbers A6181146
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2016