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


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Metastatic Renal Cell Carcinoma, Gastrointestinal Stromal Tumors

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Trial Information

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


Open label


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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.

Outcome Time Frame:

36 weeks

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Philippines: Bureau of Food and Drugs

Study ID:

A6181118

NCT ID:

NCT01073644

Start Date:

February 2010

Completion Date:

December 2013

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Gastrointestinal Stromal Tumors
  • imatinib resistant or intolerant
  • Carcinoma
  • Carcinoma, Renal Cell
  • Gastrointestinal Stromal Tumors

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