Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Study Overview
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Brief Summary
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To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)

Detailed Description
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All the patients prescribed according to approved indications at contracted institutions

Official Title
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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Conditions
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Gastrointestinal Stromal Tumors

Intervention / Treatment
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* Drug: Sunitinib malate
* Drug: Sunitinib malate
* Drug: sunitinib malate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate | Drug: Sunitinib malate<br>* Sunitinib : dosing not pre-determined<br>|
| 2<br>patients diagnosed as advanced RCC | Drug: Sunitinib malate<br>* Sunitinib : dosing not pre-determined<br>|
| 3<br>patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma | Drug: sunitinib malate<br>* Sunitinib : dosing not pre-determined<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as unlikely or no (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. | From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST) | The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions. | At the end of study treatment, average of 23.2 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUTENE, post-marketing surveillance, GIST, RCC, Korea