Clinical trial NCT00444795: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Official title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumors
Keywords: SUTENE
post-marketing surveillance
GIST
RCC
Korea
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
timeFrame: 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:
measure: 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)
timeFrame: At the end of study treatment, average of 23.2 weeks.
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Daegu
city: Nam-gu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
state: Daegu
city: Gangneung-si
country: Korea, Republic of
facility: GangNeung Asan Hospital
state: Gangwon-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Cheonnam
country: Korea, Republic of
facility: Hwasun Hospital, Chonnam National University
state: South Jeolla Province
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center (Dong-A University Hospital)
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Cheonnam
country: Korea, Republic of
facility: Hwasun Hospital, Chonnam National University
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center (DCUMC)
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Gwang Joo
country: Korea, Republic of
facility: Chosun University Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Hospital
city: Iksan -Si
country: Korea, Republic of
facility: Wonkwang University School of Medicine and Hospital (WUH)
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Nam-gu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital (SNUH)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital / Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Dept. of Medicine, Div. of Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center/Division of Hematology-Oncology, Department of Medicine
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center/Department of Oncology
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul ST. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju College of Medicine, Wonju Christian Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: