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

Purpose

To monitor use in real practice including adverse events and efficacy on Sutene 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 Sunitinib malate 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:	January 2008
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 doesn't 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

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181146
First Received:	March 7, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00444795
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:

Digestive System Neoplasms

Gastrointestinal Diseases

Urogenital Neoplasms

Renal cancer

Kidney cancer

Urologic Neoplasms

Carcinoma

Digestive System Diseases

Urologic Diseases

Sunitinib

Kidney Neoplasms

Carcinoma, Renal Cell

Gastrointestinal Neoplasms

Kidney Diseases

Gastrointestinal Stromal Tumors

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

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