CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Sorafenib and Temozolomidedrug
Likely dose
Sorafenib and Temozolomide 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/NCT00597493
NCT00597493Phase 2Completed
CompareCT.gov

Phase 2 Study of Sorafenib Plus Protracted Temozolomide in Recurrent Glioblastoma Multiforme

Duke University·interventional·Posted Jan 18, 2008·Updated Jun 24, 2013

In Brief

A Phase 2 clinical trial evaluating Sorafenib and Temozolomide for Recurrent Glioblastoma Multiforme. Completed, enrolled 32 participants across 1 site.

Detailed Summary

PURPOSE AND OBJECTIVES: Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS. Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib plus temozolomide; To determine the pharmacokinetics of Sorafenib when combined with temozolomide in patients on and not on concurrent EIAC medications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Glioblastoma Multiforme
CountriesUnited States
CollaboratorsBayer, Schering-Plough

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2008
Enrollment StartSep 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.5 years ago

Interventions

Sorafenib and Temozolomidedrug

Temozolomide (50 mg per meter-squared of body surface area)every day by mouth in combination with sorafenib. Sorafenib will be taken by mouth twice every day. The dose of sorafenib will be 400 mg (2 x 200mg tablets).