Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00444795
First received: March 7, 2007
Last updated: September 8, 2014
Last verified: September 2014
  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:
  • To monitor use in real practice including adverse events on SUTENE capsules (Sunitinib malate) [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: December 2007
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 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

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

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00444795     History of Changes
Other Study ID Numbers: A6181146
Study First Received: March 7, 2007
Last Updated: September 8, 2014
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
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014