Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444795
• Other study ID #: A6181146
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2007
• Last updated: October 6, 2015
• Start date: December 2007
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)

Description:

All the patients prescribed according to approved indications at contracted institutions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Sunitinib malate
Sunitinib : dosing not pre-determined
• Sunitinib malate
Sunitinib : dosing not pre-determined
• sunitinib malate
Sunitinib : dosing not pre-determined

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To monitor use in real practice including adverse events on SUTENE capsules (Sunitinib malate)		8 years	Yes
Secondary	Efficacy		8 years	No

External Links

•   To obtain contact information for a study center near you, click here.