A Phase III Randomized, Open-Label Study of Atebimetinib in Combination with the Modified Gemcitabine and nab-Paclitaxel Regimen Versus the Standard Gemcitabine and nab-Paclitaxel Regimen for the Treatment of Patients with Metastatic Pancreatic Ductal Adenocarcinoma Cancer (MAPKeeper 301)
Categories (click each to see list of all clinical trials associated with that category): GI (ONC), Pancreatic Cancer Center of Excellence - PCCE (ONC)
Current Status: Open
Phase: III
Principal Investigator: Krishnan, Mridula
Eligibility: https://clinicaltrials.gov/study/NCT07562152?term=NCT07562152&viewType=Card&rank=1&tab=study#participation-criteria
Summary
Primary Objective:
To evaluate the overall survival (OS) of atebimetinib in combination with modified gemcitabine plus nabpaclitaxel (mGnP) versus gemcitabine plus nabpaclitaxel (GnP) in participants with previously untreated metastatic pancreatic adenocarcinoma.
Secondary Objectives:
To evaluate the progression-free survival (PFS) of atebimetinib in combination with mGnP versus GnP in participants with previously untreated metastatic pancreatic adenocarcinoma.
To evaluate the overall response rate (ORR) of atebimetinib in combination with mGnP versus GnP in participants with previously untreated metastatic pancreatic adenocarcinoma.
To evaluate the disease control rate (DCR) of atebimetinib in combination with mGnP versus GnP in participants with previously untreated metastatic pancreatic adenocarcinoma.
To characterize the safety and tolerability of atebimetinib in combination with mGnP.
To evaluate changes to participants' cancer symptoms and quality of life following administration of atebimetinib in combination with mGnP versus GnP in participants' previously untreated metastatic pancreatic adenocarcinoma.