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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Completed
Conditions
Gastrointestinal Stromal Tumors
Interventions
Registration Number
NCT00444795
Lead Sponsor
Pfizer
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
520
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
1sunitinib malatepatients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate
2sunitinib malatepatients diagnosed as advanced RCC
3sunitinib malatepatients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRsFrom 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.

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.

Secondary Outcome Measures
NameTimeMethod
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)At the end of study treatment, average of 23.2 weeks.

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.

Trial Locations

Locations (44)

Hwasun Hospital, Chonnam National University

🇰🇷

Cheonnam, Korea, Republic of

Soonchunhyang University Bucheon Hospital

🇰🇷

Bucheon, Gyeonggi-do, Korea, Republic of

Chosun University Hospital

🇰🇷

Gwang Joo, Korea, Republic of

Keimyung University Dongsan Medical Center

🇰🇷

Jung-gu, Daegu, Korea, Republic of

Keimyung University Dongsan Hospital

🇰🇷

Daegu, Korea, Republic of

Hallym University Sacred Heart Hospital

🇰🇷

Anyang, Korea, Republic of

Kangbuk Samsung Hospital

🇰🇷

Seoul, Korea, Republic of

Kyung Hee University Medical Center

🇰🇷

Seoul, Korea, Republic of

Daegu Catholic University Medical Center (DCUMC)

🇰🇷

Daegu, Korea, Republic of

Gangnam Severance Hospital, Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Seoul National University Bundang Hospital

🇰🇷

Seongnam-si, Korea, Republic of

Samsung Medical Center/Division of Hematology-Oncology, Department of Medicine

🇰🇷

Seoul, Korea, Republic of

Chonbuk National University Hospital

🇰🇷

Jeonju, Korea, Republic of

Seoul National University Hospital (SNUH)

🇰🇷

Seoul, Korea, Republic of

Korea University Anam Hospital

🇰🇷

Seoul, Korea, Republic of

Seoul ST. Mary's Hospital

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center, Dept. of Medicine, Div. of Hematology/Oncology

🇰🇷

Seoul, Korea, Republic of

KyungHee University Medical Center

🇰🇷

Seoul, Korea, Republic of

Ulsan University Hospital

🇰🇷

Ulsan, Korea, Republic of

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

🇰🇷

Wonju-si, Korea, Republic of

Daegu Catholic University Medical Center

🇰🇷

Nam-gu, Daegu, Korea, Republic of

GangNeung Asan Hospital

🇰🇷

Gangneung-si, Gangwon-do, Korea, Republic of

Pusan National University Hospital

🇰🇷

Gyeongsangnam-do, Korea, Republic of

Inje University Ilsan Paik Hospital

🇰🇷

Goyang, Korea, Republic of

Dong-A University Medical Center (Dong-A University Hospital)

🇰🇷

Busan, Korea, Republic of

Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology

🇰🇷

Busan, Korea, Republic of

Kyungpook National University Medical Center

🇰🇷

Daegu, Korea, Republic of

Chungnam National University Hospital

🇰🇷

Daejeon, Korea, Republic of

Eulji University Hospital

🇰🇷

Daejeon, Korea, Republic of

Seoul National University Hospital / Department of Internal Medicine

🇰🇷

Seoul, Korea, Republic of

Gachon University Gil Hospital

🇰🇷

Incheon, Korea, Republic of

Severance Hospital, Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center/Department of Oncology

🇰🇷

Seoul, Korea, Republic of

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

🇰🇷

Suwon, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Korea Cancer Center Hospital

🇰🇷

Seoul, Korea, Republic of

Korea University Guro Hospital

🇰🇷

Seoul, Korea, Republic of

Kosin University Gospel Hospital

🇰🇷

Busan, Korea, Republic of

Ewha Womans University Mokdong Hospital

🇰🇷

Seoul, Korea, Republic of

Yeungnam University Medical Center

🇰🇷

Nam-gu, Korea, Republic of

Dong-A University Hospital

🇰🇷

Busan, Korea, Republic of

Wonkwang University School of Medicine and Hospital (WUH)

🇰🇷

Iksan -Si, Korea, Republic of

Inha University Hospital

🇰🇷

Incheon, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

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