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

This study has been 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.)
Information provided by (Responsible Party):
Pfizer Identifier:
First received: February 22, 2010
Last updated: July 3, 2013
Last verified: July 2013
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.

Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Sunitinib malate
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sunitinb malate Drug: Sunitinib malate
sunitinib 50 mg, 4 weeks on, 2 weeks off
Other Name: Sutent

Detailed Description:
Open label

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population will be selected by primary care clinic.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01073644

Chong Hua Hospital
Cebu City, Philippines
Private Clinic
Manila, Philippines
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01073644     History of Changes
Other Study ID Numbers: A6181118 
Study First Received: February 22, 2010
Last Updated: July 3, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Pfizer:
imatinib resistant or intolerant

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 03, 2016