Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

N/ACompletedNCT00444795

Pfizer520 enrolled

Overview

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

All the patients prescribed according to approved indications at contracted institutions

Study Type

OBSERVATIONAL

Enrollment

520

Conditions

Gastrointestinal Stromal Tumors

Interventions

Sunitinib malateDRUG

Sunitinib : dosing not pre-determined

Sunitinib malateDRUG

Sunitinib : dosing not pre-determined

sunitinib malateDRUG

Sunitinib : dosing not pre-determined

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (47)

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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.

Time frame: At the end of study treatment, average of 23.2 weeks.

Data from ClinicalTrials.gov

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Keimyung University Dongsan Medical Center

Jung-gu, Daegu, South Korea

Daegu Catholic University Medical Center

Nam-gu, Daegu, South Korea

GangNeung Asan Hospital

Gangneung-si, Gangwon-do, South Korea

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Seoul National University Hospital (SNUH)

Seoul, Seoul, South Korea

Hwasun Hospital, Chonnam National University

Cheonnam, South Jeolla Province, South Korea

Hallym University Sacred Heart Hospital

Anyang, South Korea

Pusan National University Hospital

Busan, South Korea

Kosin University Gospel Hospital

Busan, South Korea

...and 37 more locations