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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene


Phase 4
N/A
N/A
Open (Enrolling by invite only)
Both
Gastrointestinal Stromal Tumors, Carcinoma, Renal Cell (Advanced), Pancreatic Neuroendocrine Carcinoma

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Trial Information

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene


All the patients prescribed according to approved indications at contracted institutions


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To monitor use in real practice including adverse events on SUTENE capsules (Sunitinib malate)

Outcome Time Frame:

8 years

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

A6181146

NCT ID:

NCT00444795

Start Date:

December 2007

Completion Date:

February 2015

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Carcinoma, Renal Cell (Advanced)
  • Pancreatic Neuroendocrine Carcinoma
  • SUTENE
  • post-marketing surveillance
  • GIST
  • RCC
  • Korea
  • Carcinoma
  • Carcinoma, Renal Cell
  • Carcinoma, Neuroendocrine
  • Gastrointestinal Stromal Tumors
  • Carcinoma, Islet Cell

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