Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
nab-paclitaxel · 1 trial · 1 indication
OS from time of randomization will be calculated using the Kaplan-Meier method and compared between the test and control groups using the stratified Wilcoxin Test
| Arm | Type | Description |
|---|---|---|
| IA Therapy | EXPERIMENTAL | IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks. |
| IV Therapy | ACTIVE_COMPARATOR | IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes. |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Chemotherapy |
| nab-paclitaxel | DRUG | Chemotherapy |
| RenovoCath | DEVICE | Intra-arterial catheter |
Inclusion Criteria: 1. Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 8 weeks of consent for patients who enroll at cycle 1, and from the start of cycle 1 of gemcitabine + nab-paclitaxel chemotherapy for patients who enroll at cycle 2 2. Locally ad...