Clinical trial NCT00716820: Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
Official title: Outcome Survey Of Specific Use Of 12.5 Mg Sutent Capsule Against Gastrointestinal Stromal Tumor: Implementation Guidelines.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 472
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A6181175 prescribes the SUNITINIB MALATE(Sutent).

Brief summary: 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.

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

Eligibility 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).

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: MAX 2 Years
measure: Objective Response Rate
timeFrame: MAX 2 Years
Secondary outcomes:
measure: Objective Response Rates by KIT Expression Status
timeFrame: MAX 2 Years
measure: Objective Response Rates by c-Kit Mutation Status
timeFrame: MAX 2 Years
measure: Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events in Elderly Population
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment
timeFrame: MAX 2 Years
measure: Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation
timeFrame: MAX 2 Years
Other outcomes:
measure: Number of Participants With Treatment-Related Serious Adverse Events
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: MAX 2 Years
measure: Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)
timeFrame: MAX 2 Years
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: