CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,674 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/NCT00716625
NCT00716625N/ACompleted
CompareCT.gov

Special Investigation For RCC Of Sutent (Regulatory Post Marketing Commitment Plan).

Pfizer·observational·Posted Jul 16, 2008·Updated May 3, 2023

In Brief

An observational study evaluating sunitinib malate for Carcinoma, Renal Cell. Completed, enrolled 1,674 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--
ConditionsCarcinoma, Renal Cell
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.3 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."