A Phase 3 Randomized, Open-Label Study of Atebimetinib Combined With Modified Gemcitabine and Nab-Paclitaxel Versus Standard Gemcitabine and Nab-Paclitaxel for Patients With Metastatic Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of atebimetinib combined with a modified schedule of gemcitabine and nab-paclitaxel compared to the standard gemcitabine and nab-paclitaxel treatment in patients with metastatic pancreatic adenocarcinoma. This Phase 3, global, open-label, randomized study aims to see if the new combination improves overall survival when used as the first treatment for this condition. Participants will be randomly assigned to one of two groups: one group will receive atebimetinib as once-daily oral tablets along with biweekly intravenous infusions of gemcitabine and nab-paclitaxel (modified dosing), while the other group will receive the standard weekly intravenous infusions of gemcitabine and nab-paclitaxel for three weeks followed by a one-week break. This treatment period is expected to last up to approximately two years. During the study, participants will be monitored regularly for overall survival, progression-free survival, response rates, disease control, and quality of life using questionnaires. Researchers will also track adverse events and safety throughout. The trial involves assessments like imaging to measure disease and laboratory tests to check organ function. Participation may last up to about two years with ongoing evaluation of treatment effects and patient well-being.

Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma