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

NCT00797940 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-12-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sophiris Bio Corp

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00797940 on ClinicalTrials.gov