Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
1 other identifier
observational
520
1 country
47
Brief Summary
To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2007
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2007
CompletedFirst Posted
Study publicly available on registry
March 8, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
April 26, 2016
CompletedFebruary 1, 2017
December 1, 2016
7.8 years
March 7, 2007
February 19, 2016
December 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (3)
1
patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate
2
patients diagnosed as advanced RCC
3
patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma
Interventions
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (47)
Keimyung University Dongsan Medical Center
Jung-gu, Daegu, 100-712, South Korea
Daegu Catholic University Medical Center
Nam-gu, Daegu, 705-718, South Korea
GangNeung Asan Hospital
Gangneung-si, Gangwon-do, 210-711, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723, South Korea
Seoul National University Hospital (SNUH)
Seoul, Seoul, 110-744, South Korea
Hwasun Hospital, Chonnam National University
Cheonnam, South Jeolla Province, 519-809, South Korea
Hallym University Sacred Heart Hospital
Anyang, 431-070, South Korea
Pusan National University Hospital
Busan, 602 739, South Korea
Kosin University Gospel Hospital
Busan, 602-702, South Korea
Dong-A University Hospital
Busan, 602-715, South Korea
Dong-A University Medical Center (Dong-A University Hospital)
Busan, 602-715, South Korea
Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology
Busan, 602-715, South Korea
Pusan National University Hospital
Busan, 602-739, South Korea
Hwasun Hospital, Chonnam National University
Cheonnam, 519-809, South Korea
Keimyung University Dongsan Hospital
Daegu, 700 712, South Korea
Kyungpook National University Medical Center
Daegu, 702-210, South Korea
Daegu Catholic University Medical Center (DCUMC)
Daegu, 705-718, South Korea
Chungnam National University Hospital
Daejeon, 301-721, South Korea
Eulji University Hospital
Daejeon, 302-799, South Korea
Inje University Ilsan Paik Hospital
Goyang, 411-706, South Korea
Chosun University Hospital
Gwang Joo, 501-717, South Korea
Pusan National University Hospital
Gyeongsangnam-do, 626-770, South Korea
Wonkwang University School of Medicine and Hospital (WUH)
Iksan -Si, South Korea
Inha University Hospital
Incheon, 400-711, South Korea
Gachon University Gil Hospital
Incheon, 405-760, South Korea
Chonbuk National University Hospital
Jeonju, 561-712, South Korea
Yeungnam University Medical Center
Nam-gu, 705-717, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Seoul National University Hospital / Department of Internal Medicine
Seoul, 110-744, South Korea
Kangbuk Samsung Hospital
Seoul, 110-746, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Kyung Hee University Medical Center
Seoul, 130-872, South Korea
KyungHee University Medical Center
Seoul, 130-872, South Korea
Samsung Medical Center, Dept. of Medicine, Div. of Hematology/Oncology
Seoul, 135-710, South Korea
Samsung Medical Center/Division of Hematology-Oncology, Department of Medicine
Seoul, 135-710, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 135-720, South Korea
Korea University Anam Hospital
Seoul, 136-705, South Korea
Asan Medical Center/Department of Oncology
Seoul, 138-736, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Korea Cancer Center Hospital
Seoul, 139-706, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 158-710, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Seoul ST. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, 682-714, South Korea
Yonsei University Wonju College of Medicine, Wonju Christian Hospital
Wŏnju, 220-701, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2007
First Posted
March 8, 2007
Study Start
May 1, 2007
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
February 1, 2017
Results First Posted
April 26, 2016
Record last verified: 2016-12