A Phase 1/2 study to determine the effect of Doxorubicin loaded EnGeneIC Delivery Vehicles on progression free survival in Patients with Recurrent Glioblastoma Multiforme (GBM)
Phase 1
- Conditions
- Recurrent Glioblastoma MultiformeCancer - Brain
- Registration Number
- ACTRN12613000297729
- Lead Sponsor
- EnGeneIC Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
Patients with pathologically documented, and definitively diagnosed recurrent WHO Grade IV advanced malignant GBM which expresses EGFR.
Exclusion Criteria
Previous treatment with bevacizumab or anti-angiogenic therapy, treatment with immunotherapeutic agents, vaccines, or monoclonal antibody in past 4 weeks. Known allergy or sensitivity to any of the excipients in the investigational product
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess six month progression free survival (6PFS) according to the Response Assessment in Neuro-Oncology (RANO) in recurrent GBM.[6 months]
- Secondary Outcome Measures
Name Time Method