CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Erlotinib + sirolimusdrug
Likely dose
Erlotinib + sirolimus 150 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/NCT00672243
NCT00672243Phase 2Completed
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Phase II Trial of Erlotinib Plus Sirolimus for Patients With Recurrent Malignant Glioma Multiforme

Duke University·interventional·Posted May 6, 2008·Updated Aug 7, 2013

In Brief

A Phase 2 clinical trial evaluating Erlotinib + sirolimus for Glioblastoma and Gliosarcoma. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Primary objective: To determine the 6-month progression free survival of patients with recurrent glioblastoma multiforme (GBM) treated with Erlotinib plus Sirolimus. Secondary objectives: To further define the safety and tolerability of Erlotinib plus Sirolimus when administered to patients with recurrent GBM; and to evaluate progression free survival, radiographic response and overall survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma, Gliosarcoma
CountriesUnited States
CollaboratorsGenentech, Inc., OSI Pharmaceuticals

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 6, 2008
Enrollment StartApr 1, 2007
Primary CompletionSep 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.2 years ago

Interventions

Erlotinib + sirolimusdrug

Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of oral erlotinib and 5mg of oral sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of oral erlotinib and 10 mg of oral sirolimus for patients on concurrent EIAEDS.