Gastrointestinal Stromal TumorsNCT00444795
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
An observational study of Gastrointestinal Stromal Tumors, run by Pfizer at 47 sites in South Korea.
Trial summary
To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Sunitinib malate
- How many people
- 520 participants
- Where
- 47 sitesSouth Korea
- Study dates
- May 2007to Mar 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
South Korea47 sites
Hallym University Sacred Heart Hospital
Anyang, 431-070
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
Pusan National University Hospital
Busan, 602 739
Kosin University Gospel Hospital
Busan, 602-702
Dong-A University Hospital
Busan, 602-715
Dong-A University Medical Center (Dong-A University Hospital)
Busan, 602-715
Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology
Busan, 602-715
Pusan National University Hospital
Busan, 602-739
Hwasun Hospital, Chonnam National University
Cheonnam, South Jeolla Province, 519-809
Hwasun Hospital, Chonnam National University
Cheonnam, 519-809
Keimyung University Dongsan Hospital
Daegu, 700 712
Kyungpook National University Medical Center
Daegu, 702-210
Daegu Catholic University Medical Center (DCUMC)
Daegu, 705-718
Chungnam National University Hospital
Daejeon, 301-721
Eulji University Hospital
Daejeon, 302-799
GangNeung Asan Hospital
Gangneung-si, Gangwon-do, 210-711
Inje University Ilsan Paik Hospital
Goyang, 411-706
Chosun University Hospital
Gwang Joo, 501-717
Pusan National University Hospital
Gyeongsangnam-do, 626-770
Wonkwang University School of Medicine and Hospital (WUH)
Iksan -Si
Inha University Hospital
Incheon, 400-711
Gachon University Gil Hospital
Incheon, 405-760
Chonbuk National University Hospital
Jeonju, 561-712
Keimyung University Dongsan Medical Center
Jung-gu, Daegu, 100-712
Daegu Catholic University Medical Center
Nam-gu, Daegu, 705-718
Yeungnam University Medical Center
Nam-gu, 705-717
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Seoul National University Hospital (SNUH)
Seoul, Seoul, 110-744
Seoul National University Hospital / Department of Internal Medicine
Seoul, 110-744
Kangbuk Samsung Hospital
Seoul, 110-746
Severance Hospital, Yonsei University Health System
Seoul, 120-752
Kyung Hee University Medical Center
Seoul, 130-872
KyungHee University Medical Center
Seoul, 130-872
Samsung Medical Center, Dept. of Medicine, Div. of Hematology/Oncology
Seoul, 135-710
Samsung Medical Center/Division of Hematology-Oncology, Department of Medicine
Seoul, 135-710
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 135-720
Korea University Anam Hospital
Seoul, 136-705
Asan Medical Center/Department of Oncology
Seoul, 138-736
Asan Medical Center
Seoul, 138-736
Korea Cancer Center Hospital
Seoul, 139-706
Korea University Guro Hospital
Seoul, 152-703
Ewha Womans University Mokdong Hospital
Seoul, 158-710
Seoul National University Hospital
Seoul, 3080
Seoul ST. Mary's Hospital
Seoul
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723
Ulsan University Hospital
Ulsan, 682-714
Yonsei University Wonju College of Medicine, Wonju Christian Hospital
Wŏnju, 220-701
About this study
To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)
Read the detailed description
All the patients prescribed according to approved indications at contracted institutions
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Sunitinib malate
- Keywords
- SUTENE, post-marketing surveillance, GIST, RCC, Korea
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib malateDrug
Sunitinib : dosing not pre-determined
Sunitinib malateDrug
Sunitinib : dosing not pre-determined
sunitinib malateDrug
Sunitinib : dosing not pre-determined
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate Receives: Drug: Sunitinib malate | |
| 2 | patients diagnosed as advanced RCC Receives: Drug: Sunitinib malate | |
| 3 | patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma Receives: Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: At the end of study treatment, average of 23.2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444795
- Sponsor's protocol ID
- A6181146
- Status last verified
- Dec 2016
- First submitted
- 7 Mar 2007
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
- ClinicalTrials.gov ID
- NCT00444795
- Acronym / sponsor ID
- A6181146
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- SUTENE, post-marketing surveillance, GIST, RCC, Korea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Posted 26 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Sunitinib malatepatients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate |
| 2 | – | Drug: Sunitinib malatepatients diagnosed as advanced RCC |
| 3 | – | Drug: sunitinib malatepatients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunitinib malateSunitinib : dosing not pre-determined | Drug | 1 |
| Sunitinib malateSunitinib : dosing not pre-determined | Drug | 2 |
| sunitinib malateSunitinib : dosing not pre-determined | Drug | 3 |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumors, run by Pfizer at 47 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.