Metastatic Renal Cell Carcinoma
Conditions
Keywords
imatinib resistant or intolerant
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
Interventions
DRUGSunitinib malate
sunitinib 50 mg, 4 weeks on, 2 weeks off
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Philippines
Outcome results
None listed