Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
- Registration Number
- NCT01073644
- Lead Sponsor
- Pfizer
- Brief Summary
The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal stromal tumor among filipino patients in usual clinical practice setting.
- Detailed Description
Open label
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sunitinb malate Sunitinib malate -
- Primary Outcome Measures
Name Time Method 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. 36 weeks
- Secondary Outcome Measures
Name Time Method Effectiveness of sunitinib malate will be measured by the overall response as determined by the objective tumor assessments made according to the Response Evaluation Criteria in Solid Tumors (RECIST). 36 weeks
Trial Locations
- Locations (2)
Chong Hua Hospital
🇵🇭Cebu City, Philippines
Private Clinic
🇵🇭Manila, Philippines