Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

NCT ID: NCT00444795

Last Updated: 2017-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2015-03-31

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

Conditions

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Gastrointestinal Stromal Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate

Sunitinib malate

Intervention Type DRUG

Sunitinib : dosing not pre-determined

2

patients diagnosed as advanced RCC

Sunitinib malate

Intervention Type DRUG

Sunitinib : dosing not pre-determined

3

patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma

sunitinib malate

Intervention Type DRUG

Sunitinib : dosing not pre-determined

Interventions

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Sunitinib malate

Sunitinib : dosing not pre-determined

Intervention Type DRUG

Sunitinib malate

Sunitinib : dosing not pre-determined

Intervention Type DRUG

sunitinib malate

Sunitinib : dosing not pre-determined

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Keimyung University Dongsan Medical Center

Jung-gu, Daegu, South Korea

Site Status

Daegu Catholic University Medical Center

Nam-gu, Daegu, South Korea

Site Status

GangNeung Asan Hospital

Gangneung-si, Gangwon-do, South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status

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

Suwon, Gyeonggi-do, South Korea

Site Status

Seoul National University Hospital (SNUH)

Seoul, Seoul, South Korea

Site Status

Hwasun Hospital, Chonnam National University

Cheonnam, South Jeolla Province, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

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

Busan, , South Korea

Site Status

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

Busan, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Hwasun Hospital, Chonnam National University

Cheonnam, , South Korea

Site Status

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status

Kyungpook National University Medical Center

Daegu, , South Korea

Site Status

Daegu Catholic University Medical Center (DCUMC)

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Eulji University Hospital

Daejeon, , South Korea

Site Status

Inje University Ilsan Paik Hospital

Goyang, , South Korea

Site Status

Chosun University Hospital

Gwang Joo, , South Korea

Site Status

Pusan National University Hospital

Gyeongsangnam-do, , South Korea

Site Status

Wonkwang University School of Medicine and Hospital (WUH)

Iksan -Si, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Gachon University Gil Hospital

Incheon, , South Korea

Site Status

Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Yeungnam University Medical Center

Nam-gu, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Seoul National University Hospital / Department of Internal Medicine

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Kyung Hee University Medical Center

Seoul, , South Korea

Site Status

KyungHee University Medical Center

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Asan Medical Center/Department of Oncology

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Korea Cancer Center Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Seoul ST. Mary's Hospital

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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A6181146

Identifier Type: -

Identifier Source: org_study_id

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