CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Sunitinib Malatedrug
Likely dose
Sunitinib Malate 50mgfrom 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/NCT00672594
NCT00672594Phase 2Completed

Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

Duke University·interventional·Posted May 6, 2008·Updated Aug 4, 2014

In Brief

A Phase 2 clinical trial evaluating Sunitinib Malate for Prostate Cancer and Prostatectomy. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 6, 2008
Enrollment StartJul 1, 2006
Primary CompletionSep 1, 2012
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 18.2 years ago

Interventions

Sunitinib Malatedrug

Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks