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...
Nab-paclitaxel is being studied for the treatment of Locally Advanced Pancreatic Cancer (LAPC). It is part of an investigational regimen being evaluated in a Phase 3 clinical trial, where it is combined with gemcitabine and administered following radiotherapy. The drug is not yet approved for this indication and remains in clinical development.
Nab-paclitaxel targets multiple tubulin proteins, including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as an inhibitor of these targets, which are components of microtubules, thereby interfering with cell division processes in cancer cells.
Nab-paclitaxel is being developed by RenovoRx, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol RNXT. The company is conducting clinical research to evaluate the drug's efficacy in treating Locally Advanced Pancreatic Cancer.
Nab-paclitaxel is currently in Phase 3 clinical development for Locally Advanced Pancreatic Cancer. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and effectiveness in patients.
Nab-paclitaxel is being evaluated in a single Phase 3 clinical trial registered as NCT03257033. This trial, titled 'Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC,' is actively recruiting participants with Locally Advanced Pancreatic Cancer in the United States and Belgium, with a target enrollment of 190 patients.