Trial Information
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
All the patients prescribed according to approved indications at contracted institutions
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
To monitor use in real practice including adverse events on SUTENE capsules (Sunitinib malate)
Outcome Time Frame:
8 years
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
A6181146
NCT ID:
NCT00444795
Start Date:
December 2007
Completion Date:
February 2015
Related Keywords:
- Gastrointestinal Stromal Tumors
- Carcinoma, Renal Cell (Advanced)
- Pancreatic Neuroendocrine Carcinoma
- SUTENE
- post-marketing surveillance
- GIST
- RCC
- Korea
- Carcinoma
- Carcinoma, Renal Cell
- Carcinoma, Neuroendocrine
- Gastrointestinal Stromal Tumors
- Carcinoma, Islet Cell