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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00634231 | A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors | PHASE1 | COMPLETED | 8 | — | — | Oct 1, 2010 | Jun 1, 2021 | Aug 25, 2023 | 2 | United States |
| NCT00751270 | Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas | PHASE1 | COMPLETED | 15 | — | — | Nov 1, 2005 | Jan 1, 2011 | Aug 25, 2023 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| AdV-tk | EXPERIMENTAL | AdV-tk + valacyclovir in combination with standard of care radiation |
| A | EXPERIMENTAL | Arm A for unresectable malignant glioma was closed due to poor accrual. |
| B | EXPERIMENTAL | Arm B for resectable malignant glioma completed the Phase I accrual and long term follow up continues. A follow on study at dose level 3 was opened as a Phase 2a study (see BrTK02). |
| Name | Type | Description |
|---|---|---|
| AdV-tk | BIOLOGICAL | - |
| valacyclovir | DRUG | - |
| Radiation | RADIATION | - |
Inclusion Criteria: * Patients must be 3 years of age or older * Patients must be planning to undergo standard of care treatment with surgery and radiation therapy. * Patients must have malignant glioma or recurrent ependymoma * Tumor must be accessible for injection and must not be located in the ...