Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
NCT00444795
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- 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.
- 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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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 |
| |||
Study Groups/Cohorts |
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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 | 520 | |||
Original Enrollment | 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:
Exclusion Criteria:
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Sex/Gender |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2016 |