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NCT01073644 Clinical Trial

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

Metastatic Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01073644
Other study ID # A6181118
Secondary ID
Status Terminated
Phase Phase 4
First received February 22, 2010
Last updated July 3, 2013
Start date February 2010
Est. completion date April 2010

Study information
Verified date July 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Observational

Clinical Trial 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.

Description:

Open label

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Sunitinib malate
sunitinib 50 mg, 4 weeks on, 2 weeks off

Locations
Country Name City State
Philippines Chong Hua Hospital Cebu City
Philippines Private Clinic Manila

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 No
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