N/A N=620

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Gastrointestinal Stromal Tumors

Bottom Line

View on ClinicalTrials.gov: NCT00444795 ↗

Enrolled (actual)

620

Serious AEs

11.7%

Results posted

Apr 2016

Primary outcome: Primary: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs — 80.23; 76.50; 11.67; 7.46 Percentage of Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Sunitinib malate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs	80.23; 76.50; 11.67; 7.46; 44.57; 35.17	—
SECONDARY 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)	77.48	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00444795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.