CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
IL13-PE38QQR +3 moredrug
Likely dose
Not stated in 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/NCT00076986
NCT00076986Phase 3Completed
CompareCT.gov

PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL® Wafer With Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence

INSYS Therapeutics Inc·interventional·Posted Feb 10, 2004·Updated Jun 6, 2011

In Brief

A Phase 3 clinical trial evaluating IL13-PE38QQR, surgery and catheter placement (2 procedures), and 2 other interventions for Glioblastoma Multiforme. Completed, across 60 sites in 6 countries.

Detailed Summary

The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma Multiforme
CountriesCanada, Germany, Israel, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2004
Enrollment StartFeb 1, 2004
Primary CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 22.4 years ago

Interventions

IL13-PE38QQRdrug

surgery and catheter placement (2 procedures)procedure

prolifespan 20 with carmustine implant (GLIADEL® Wafer)drug

surgery and wafer placement (1 procedure)procedure