CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 186 enrolled
Drug / intervention
SUTENTdrug
Likely dose
SUTENT 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/NCT00684645
NCT00684645N/ACompleted
CompareCT.gov

Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

Pfizer·observational·Posted May 26, 2008·Updated Aug 21, 2012

In Brief

An observational study evaluating SUTENT for Metastatic Renal Cell Carcinoma. Completed, enrolled 186 participants across 20 sites.

Detailed Summary

Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Renal Cell Carcinoma
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.1 years ago

Interventions

SUTENTdrug

SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity.