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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01997190 | Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion | PHASE1 | COMPLETED | 19 | — | — | Oct 1, 2013 | Feb 1, 2018 | Aug 25, 2023 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Study Arm | EXPERIMENTAL | AdV-tk + valacyclovir |
| Name | Type | Description |
|---|---|---|
| AdV-tk + valacyclovir | BIOLOGICAL | AdV-tk will be administered intrapleural through pleural catheter followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration. |
Inclusion Criteria: * Patients must have MPE (defined as positive pleural fluid cytology). Eligible patients include NSCLC, small cell lung cancer, malignant mesothelioma (MM), breast cancer and ovarian cancer. Diagnosis must be made prior to AdV-tk injection. For patients with MM, histologic proof...