Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan). - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00716820

Purpose

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: SUNITINIB MALATE	Phase IV

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Special Investigation For Gist Of Sutent (Regulatory Post Marketing Commitment Plan).

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib Malic acid

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
The incidence of adverse drug reactions in this surveillance. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Follow up for safety information. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
SUNITINIB MALATE Patients taking Sutent.	Drug: SUNITINIB MALATE SUTENT capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated. The dosage may be decreased according to the patient's clinical condition."

Groups/Cohorts

Assigned Interventions

SUNITINIB MALATE

Patients taking Sutent.

Drug: SUNITINIB MALATE

SUTENT capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated. The dosage may be decreased according to the patient's clinical condition."

Detailed Description:

All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.

Eligibility

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

Study Population

The patients whom an investigator involving A6181175 prescribes the SUNITINIB MALATE(Sutent).

Criteria

Inclusion Criteria:

Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered SUNITINIB MALATE(Sutent).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716820

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:	A6181175
Study First Received:	July 15, 2008
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00716820 History of Changes
Health Authority:	Japan: Institutional Review Board

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Sunitinib
Gastrointestinal Diseases

Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Angiogenesis Inhibitors

Additional relevant MeSH terms:

Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Digestive System Diseases
Sunitinib
Therapeutic Uses
Gastrointestinal Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Gastrointestinal Stromal Tumors

ClinicalTrials.gov processed this record on September 10, 2009