Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma

Phase 1

Completed

• Conditions: Recurrent Glioblastoma Planned for Reoperation

• Registration Number: NCT00715013
• Lead Sponsor: University of Zurich

Brief Summary

Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone.

* Trial with medicinal product

Detailed Description

Prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug Patupilone, a tubulin-inhibitor.

The purpose of the trial is to prolong PFS in this patient population. Patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. Side effects are expected to be manageable.

Study Timeline

• Study First Submitted: 2007-11-22
• Study Start: 2008-07
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-14
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-09-14
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression free survival	3 years
PFS, OS translational research	3 years