Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00444795
First received: March 7, 2007
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)

Condition Intervention
Gastrointestinal Stromal Tumors
Drug: Sunitinib malate
Drug: sunitinib malate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 520
Study Start Date: May 2007
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:
All the patients prescribed according to approved indications at contracted institutions
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444795

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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00444795     History of Changes
Other Study ID Numbers: A6181146 
Study First Received: March 7, 2007
Results First Received: February 19, 2016
Last Updated: March 23, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Pfizer:
SUTENE
post-marketing surveillance
GIST
RCC
Korea

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 25, 2016