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PD L 506 for iPDT in Newly Diagnosed Glioblastoma
NCT03897491Phase 2
Key facts
- Status
- Terminated
- Start
- Sep 2021
- Primary completion
- Apr 2026
- Countries
- 1
- Sponsor
- photonamic GmbH & Co. KG
- Modality
- Small Molecules
- Conditions
- glioblastoma (GBM)
01
Overview
Phase 2, open-label, single-arm trial of 5-aminolevulinic acid in glioblastoma (GBM), sponsored by photonamic GmbH & Co. KG. Primary endpoint: Incidence of treatment-emergent Adverse Events at 2 weeks. Started Sep 2021; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Interstitial photodynamic therapy
20 mg 5-aminolevulinic acid per kg body weight orally four hours before the induction of general anaesthesia, followed by iPDT.
03
Who it enrols
Adult patients (18-70 years) with newly diagnosed, supratentorial, unifocal, lobar located IDH wild-type glioblastoma (<= 40 mm diameter), KPS >= 70%, and adequate organ function.
04
Endpoints
Primary
Incidence of treatment-emergent Adverse Events
Secondary
Progression-free survival rate
Overall survival rate
Progression-free survival
Overall survival
MGMT promoter methylation status
Immune status of the patient
Karnofsky performance status
Mini-mental State Examination
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