Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients

Pfizer3 enrolled

Overview

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.

Open label

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Renal Cell Carcinoma

Interventions

Sunitinib malateDRUG

sunitinib 50 mg, 4 weeks on, 2 weeks off

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Chong Hua Hospital

Cebu City, Philippines

Private Clinic

Manila, Philippines

Outcomes

Primary Outcomes

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.

Time frame: 36 weeks

Secondary Outcomes

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).

Time frame: 36 weeks

Data from ClinicalTrials.gov

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