CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 472 enrolled
Drug / intervention
SUNITINIB MALATEdrug
Likely dose
SUNITINIB MALATE 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00716820
NCT00716820N/ACompleted
CompareCT.gov

Outcome Survey Of Specific Use Of 12.5 Mg Sutent Capsule Against Gastrointestinal Stromal Tumor: Implementation Guidelines.

Pfizer·observational·Posted Jul 16, 2008·Updated Apr 6, 2023

In Brief

An observational study evaluating SUNITINIB MALATE for Gastrointestinal Stromal Tumors. Completed, enrolled 472 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumors
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2008
Enrollment StartApr 1, 2008
Primary CompletionOct 1, 2015
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 18.0 years ago

Interventions

SUNITINIB MALATEdrug

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."