Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
Phase 4
18 Years
75 Years
18 Years
75 Years
Open (Enrolling)
Both
Metastatic Renal Cell Carcinoma, Gastrointestinal Stromal Tumors
Both
Metastatic Renal Cell Carcinoma, Gastrointestinal Stromal Tumors
Trial Information
Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
Open label
Inclusion Criteria:
- Age 18 years and above
- Diagnosed with metastatic renal cell carcinoma or gastrointestinal stromal tumor
after imatinib treatment failure or intolerance
Exclusion Criteria:
- Subjects with conditions that are contraindicated with sunitinib malate
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Safety and tolerability of sunitinib malate as measured by the incidence, severity, seriousness and relatedness to treatment adverse events (AEs), laboratory abnormalities, vital signs (blood pressure) and the use of concomitant medications.
Outcome Time Frame:
36 weeks
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Philippines: Bureau of Food and Drugs
Study ID:
A6181118
NCT ID:
NCT01073644
Start Date:
February 2010
Completion Date:
December 2013
Related Keywords:
- Metastatic Renal Cell Carcinoma
- Gastrointestinal Stromal Tumors
- imatinib resistant or intolerant
- Carcinoma
- Carcinoma, Renal Cell
- Gastrointestinal Stromal Tumors
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