Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

December 6, 2016 updated by: Pfizer
To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All the patients prescribed according to approved indications at contracted institutions

Study Type

Observational

Enrollment (Actual)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of, 431-070
        • Hallym University Sacred Heart Hospital
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 602-702
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Medical Center (Dong-A University Hospital)
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Hospital
      • Busan, Korea, Republic of, 602 739
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology
      • Cheonnam, Korea, Republic of, 519-809
        • Hwasun Hospital, Chonnam National University
      • Daegu, Korea, Republic of, 705-718
        • Daegu Catholic University Medical Center (DCUMC)
      • Daegu, Korea, Republic of, 702-210
        • Kyungpook National University Medical Center
      • Daegu, Korea, Republic of, 700 712
        • Keimyung University Dongsan Hospital
      • Daejeon, Korea, Republic of, 301-721
        • Chungnam National University Hospital
      • Daejeon, Korea, Republic of, 302-799
        • Eulji University Hospital
      • Goyang, Korea, Republic of, 411-706
        • Inje University Ilsan Paik Hospital
      • Gwang Joo, Korea, Republic of, 501-717
        • Chosun university hospital
      • Gyeongsangnam-do, Korea, Republic of, 626-770
        • Pusan National University Hospital
      • Iksan -Si, Korea, Republic of
        • Wonkwang University School of Medicine and Hospital (WUH)
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Hospital
      • Jeonju, Korea, Republic of, 561-712
        • Chonbuk National University Hospital
      • Nam-gu, Korea, Republic of, 705-717
        • Yeungnam University Medical Center
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 3080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Seoul st. mary's hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 110-746
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 139-706
        • Korea Cancer Center Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital / Department of Internal Medicine
      • Seoul, Korea, Republic of, 130-872
        • Kyunghee University Medical Center
      • Seoul, Korea, Republic of, 135-720
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 130-872
        • Kyung Hee University Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital (SNUH)
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center, Dept. of Medicine, Div. of Hematology/Oncology
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center/Division of Hematology-Oncology, Department of Medicine
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center/Department of Oncology
      • Ulsan, Korea, Republic of, 682-714
        • Ulsan University Hospital
      • Wonju-si, Korea, Republic of, 220-701
        • Yonsei University Wonju College of Medicine, Wonju Christian Hospital
    • Daegu
      • Jung-gu, Daegu, Korea, Republic of, 100-712
        • Keimyung University Dongsan Medical Center
      • Nam-gu, Daegu, Korea, Republic of, 705-718
        • Daegu Catholic University Medical Center
    • Gangwon-do
      • Gangneung-si, Gangwon-do, Korea, Republic of, 210-711
        • Gangneung Asan Hospital
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
        • SoonChunHyang University Bucheon Hospital
      • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
        • The Catholic university of Korea, St. Vincent's Hospital
    • South Jeolla Province
      • Cheonnam, South Jeolla Province, Korea, Republic of, 519-809
        • Hwasun Hospital, Chonnam National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate
Drug: Sunitinib malate
Sunitinib : dosing not pre-determined
2
patients diagnosed as advanced RCC
Drug: Sunitinib malate
Sunitinib : dosing not pre-determined
3
patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma
Drug: sunitinib malate
Sunitinib : dosing not pre-determined

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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.
At the end of study treatment, average of 23.2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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