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Convection Enhanced Localized Administration of PRX321 With Real-time Imaging for Therapy of Recurrent Glioblastoma (CLARITY-1) — CLARITY-1  

Glioblastoma Multiforme Clinical Trial

Official title:
Phase II, Multi-center, Open-Label, Single-Arm Study of Intratumoral Infusion of PRX321 in Subjects With Glioblastoma Multiforme at First Recurrence or Progression

Clinical Trial Summary

A Phase II, multi-center, open-label, single-arm study in up to 42 subjects with first recurrence or progression of GBM at up to 12 sites in Australia, Europe, Israel, and the United States. Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days.

Primary Objective:

To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral infusion of PRX321 in subjects with first recurrence or progression of glioblastoma multiforme (GBM).

Secondary Objectives:

To assess the safety of intratumoral infusion with PRX321 in subjects with recurrent or progressive GBM.

To evaluate objective response rate (ORR), duration of response (DR), overall survival (OS), and progression-free survival (PFS).

Tertiary Objective:

To evaluate the relationship of observed infusate distribution with clinical and radiological responses.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00797940
Study type Interventional
Source Sophiris Bio Corp
Contact
Status Withdrawn
Phase Phase 2
Start date January 2009
View Details
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