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Trabedersen in recurrent high-grade glioma
NCT00431561Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2003
- Primary completion
- Mar 2009
- Countries
- 6
- Sponsor
- Isarna Therapeutics
- Drugs
- trabedersen
- Conditions
- glioblastoma (GBM)anaplastic astrocytoma (AA)
01
Overview
Phase 2, randomised, open-label trial of trabedersen in glioblastoma (GBM) and anaplastic astrocytoma (AA) (3 arms), sponsored by Isarna Therapeutics. Primary endpoint: Overall Response Rate. Started Apr 2003; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Trabedersen 10 µM
Continuous intratumoral infusion of 10 µM trabedersen every other week.
Trabedersen 80 µM
Continuous intratumoral infusion of 80 µM trabedersen every other week.
Standard Care
Physician's choice of Temozolomide or PCV chemotherapy.
03
Who it enrols
Adults with histopathologically confirmed recurrent or refractory WHO grade III or IV glioma, eligible for TMZ or PCV, with KPS >= 70% and no more than two prior chemotherapy regimens.
04
Endpoints
Primary
Overall Response Rate
Secondary
Overall Survival
Six-month Overall Survival
Twelve-month Overall Survival
Six-month Progression-Free Survival
Time to Progression
Karnofsky Performance Status Change
Safety and Tolerability
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