Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03128047 | HUMC 1612: Optune NovoTTF-200A System | PHASE1 | COMPLETED | 7 | — | — | Apr 6, 2017 | Apr 5, 2025 | Jul 8, 2025 | 2 | United States |
Number of participants receiving treatment with the Optune NovoTTF-200A System with treatment-related adverse events as assessed by CTCAE v4.0.
Number of participants receiving treatment with the Optune NovoTTF-200A System with who return tolerability questionnaire and found the device tolerable
| Arm | Type | Description |
|---|---|---|
| Recurrent high grade gliomas and ependymomas | EXPERIMENTAL | Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. |
| Name | Type | Description |
|---|---|---|
| Optune NovoTTF-200A System | DEVICE | Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. |
Inclusion Criteria: * Patients must have a minimum head circumference of 44 cm * Patients must have a histologically- or cytologically-confirmed supratentorial high-grade glioma or supratentorial ependemoma. * Patients with metastatic disease involving the infratentorium or spinal cord are eligible...