drugset / Trial / NCT02234050
Trabectedin for Recurrent Grade II/III Meningioma
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.
Timeline
- Start
- 2015-07
- Primary completion
- 2017-07
- Completion
- 2019-01-16
Outcome
Missed primary endpoint
registry analysis (superiority test); Local Standard of Care vs Trabectedin; p = 0.204; Hazard Ratio (HR) 1.42 (80% CI 0.997 to 2.028); Regression, Cox NCT02234050 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trabectedin | Small molecule | 1.5 mg/m2 | — |