Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutent - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00444795

Purpose

To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors Carcinoma, Renal Cell (Advanced)	Drug: Sunitinib malate	Phase IV

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib Malic acid

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutent On The Patients With Gastrointestinal Stromal Tumor Or Advanced Renal Cell Carcinoma.

Further study details as provided by Pfizer:

Primary Outcome Measures:

To monitor use in real practice including adverse events on SUTENE capsules (Sunitinib malate) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate	Drug: Sunitinib malate Sunitinib : dosing not pre-determined
2 patients diagnosed as advanced RCC	Drug: Sunitinib malate Sunitinib : dosing not pre-determined

Detailed Description:

All the patients prescribed according to approved indications at contracted institutions

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate or patients diagnosed as advanced RCC

Criteria

Inclusion Criteria:

Patients diagnosed as gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate or advanced renal cell carcinoma (aRCC) will be included in the study.

Exclusion Criteria:

Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information will be excluded.
Patients with hypersensitivity to sunitinib malate or to any other component of Sutent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444795

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181146
Study First Received:	March 7, 2007
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00444795 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Pfizer:

SUTENE post-marketing surveillance GIST RCC Korea

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Digestive System Neoplasms
Gastrointestinal Diseases
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Carcinoma
Renal Cancer
Digestive System Diseases

Urologic Diseases
Sunitinib
Kidney Neoplasms
Carcinoma, Renal Cell
Gastrointestinal Neoplasms
Kidney Diseases
Gastrointestinal Stromal Tumors
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Sunitinib
Therapeutic Uses
Growth Inhibitors
Kidney Diseases
Angiogenesis Modulating Agents

Neoplasms by Histologic Type
Digestive System Neoplasms
Growth Substances
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Carcinoma, Renal Cell
Gastrointestinal Neoplasms
Adenocarcinoma
Gastrointestinal Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009