NCT00797940

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sophiris Bio Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	IL-4PE	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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-12-01
• First posted: 2008-11-25
• Last updated: 2012-12-03