CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 674 enrolled
Drug / intervention
Sunitinib malate +1 moredrug
Likely dose
Sunitinib malate 50 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/NCT00375674
NCT00375674Phase 3Completed

Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc

Pfizer·interventional·Posted Sep 13, 2006·Updated Sep 21, 2018

In Brief

A Phase 3 clinical trial evaluating Sunitinib malate and Placebo for Kidney Neoplasms. Completed, enrolled 674 participants across 115 sites in 22 countries.

Detailed Summary

To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, China, Colombia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Poland, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2006
Enrollment StartAug 1, 2007
Primary CompletionApr 7, 2016
Study CompletionSep 7, 2017
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 19.8 years ago

Interventions

Sunitinib malatedrug

sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.

Placeboother

Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent