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Prinomastat with Temozolomide in Newly Diagnosed Glioblastoma
NCT00004200Phase 2
Key facts
- Status
- Completed
- Start
- Oct 1999
- Primary completion
- Jan 2002
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- prinomastat
- Conditions
- glioblastoma multiforme (GBM)
01
Overview
Phase 2, randomised, double-blind trial in glioblastoma multiforme (GBM) comparing Prinomastat + Temozolomide with Placebo + Temozolomide (2 arms). Primary endpoints: One Year Survival Rate at 1 year and Progression-Free Survival. Started Oct 1999; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Prinomastat + Temozolomide
Oral prinomastat twice daily + oral temozolomide daily on days 1-5, every 28 days.
Placebo + Temozolomide
Oral placebo twice daily + oral temozolomide daily on days 1-5, every 28 days.
03
Endpoints
Primary
One Year Survival Rate
Progression-Free Survival
Secondary
Safety and Adverse Events
Quality of Life
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