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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All the patients prescribed according to approved indications at contracted institutions

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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