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

• ClinicalTrials.gov Identifier: NCT01073644
• Recruitment Status: Terminated
• First Posted: February 23, 2010
• Last Update Posted: July 4, 2013
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: February 22, 2010
• First Posted Date: February 23, 2010
• Last Update Posted Date: July 4, 2013
• Study Start Date: February 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 22, 2010): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 22, 2010): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
• Official Title: Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
• 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
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Study population will be selected by primary care clinic.
• Condition: Metastatic Renal Cell Carcinoma

Intervention

Drug: Sunitinib malate

sunitinib 50 mg, 4 weeks on, 2 weeks off

Other Name: Sutent

Study Groups/Cohorts

Sunitinb malate

Intervention: Drug: Sunitinib malate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 3, 2013): 3
• Original Estimated Enrollment (submitted: February 22, 2010): 20
• Actual Study Completion Date: April 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Philippines

Administrative Information

• NCT Number: NCT01073644
• Other Study ID Numbers: A6181118
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2013