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nab paclitaxel · 2 trials · 3 indications
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.
Determine the two-year OS rate. Two-year (2-Y) OS will be calculated as the percentage of patients who remain alive at the 2 year mark from the registration date.
Determine the rate of resection following the neoadjuvant treatment with TTFields in combination with chemotherapy. Resectability rate will be calculated as the proportion of evaluable patients undergoing R0 or R1 resection following the neoadjuvant segment of therapy.
| 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 |
| Investigational Group | EXPERIMENTAL | Nab-paclitaxel + gemcitabine + NovoTTF-200T(P) for 3 cycles (28 day cycles) Participants who have stable disease or better after the first 3 cycles of treatment will undergo pancreatectomy within 8 weeks of receiving treatment. If the surgery yields R0 or R1 then patient will receive another 3 cycles of treatment regimen (within 8 weeks of surgery). Those who do not undergo surgery will still be included in the evaluable patients for the objectives |
| 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. |
| NovoTTF-200T(P) | DEVICE | Worn \> 18 hr /day starting C1D1 until completion of cycle 3 |
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...
Nab paclitaxel is used in combination with gemcitabine for the treatment of pancreatic adenocarcinoma. It is being studied in clinical trials for locally-advanced, resectable, and front-line pancreatic cancer. The drug is administered alongside Tumor Treating Fields (TTFields) in ongoing research protocols.
Nab paclitaxel is being developed by NovoCure Limited, a company traded under the ticker NVCR. The company is investigating the drug in combination with gemcitabine for pancreatic adenocarcinoma, including in the PANOVA-3 trial and a Phase 2 study for resectable pancreatic cancer.
Nab paclitaxel is in Phase 2 clinical development for resectable pancreatic adenocarcinoma, as studied in trial NCT05624918. A Phase 3 trial, NCT03377491, has been completed. The drug remains investigational and is not yet approved for this indication.
Nab paclitaxel is being studied in two clinical trials. NCT03377491, the PANOVA-3 trial, is a completed Phase 3 study for locally-advanced pancreatic adenocarcinoma with 571 participants. NCT05624918 is a recruiting Phase 2 trial for resectable pancreatic cancer with 38 participants.
Nab paclitaxel is a small molecule that works by targeting microtubules, which are essential for cell division. By stabilizing microtubules, it disrupts cancer cell proliferation. This mechanism is being evaluated in combination with gemcitabine and Tumor Treating Fields for pancreatic adenocarcinoma.