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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03377491 | Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3) | PHASE3 | COMPLETED | 571 | — | — | May 10, 2018 | Oct 16, 2024 | Jan 21, 2026 | 199 | United States, Australia +18 |
Overall survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to overall survival of subjects treated with chemotherapy alone, measured as the period between the time of randomization and the time of death.
| Arm | Type | Description |
|---|---|---|
| NovoTTF-200T | EXPERIMENTAL | Patients receive TTFields using the NovoTTF-200T System together with gemcitabine and nab-Paclitaxel |
| Best Standard of Care | ACTIVE_COMPARATOR | Patients receive best standard of care with gemcitabine and nab-Paclitaxel |
| Name | Type | Description |
|---|---|---|
| NovoTTF-200T | DEVICE | Patients receive continuous TTFields treatment using the NovoTTF-200T device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine. |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/m\^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. |
| nab paclitaxel | DRUG | nab-paclitaxel 125 mg/m\^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle. |
Inclusion Criteria: 1. 18 years of age and older 2. Life expectancy of ≥ 3 months 3. Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas 4. Unresectable, locally advanced stage disease according to the following criteria: * Head/uncinate process: 1. Solid tumor co...