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

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ClinicalTrials.gov Identifier: NCT01073644
Recruitment Status : Terminated (The study was prematurely discontinued due to poor recruitment on 18th April 2013. There were no safety concerns that led to the decision to terminate.)
First Posted : February 23, 2010
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

February 22, 2010
February 23, 2010
July 4, 2013
February 2010
April 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01073644 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Study population will be selected by primary care clinic.
Metastatic Renal Cell Carcinoma
Drug: Sunitinib malate
sunitinib 50 mg, 4 weeks on, 2 weeks off
Other Name: Sutent
Sunitinb malate
Intervention: Drug: Sunitinib malate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
20
April 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
 
NCT01073644
A6181118
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013