A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients with Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma

The purpose of this study is to determine whether the study medications quemliclustat in combination with chemotherapy (gemcitabine and nab-paclitaxel), would be safe and effective for treating patients with a type of pancreatic cancer called pancreatic ductal adenocarcinoma (PDAC) which has spread to other parts of the body. About 85 out of 100 (85%) of all pancreatic cancers are PDAC, and cases of PDAC are expected to increase in the next 10 years due to aging population and increased rates of obesity and type 2 diabetes. Quemliclustat is an investigational medication, which has not yet been approved to treat this type of cancer. Researchers hope that using quemliclustat will help stop cancer cells from growing. Quemliclustat is given by infusion into a vein (intravenously or IV), usually with a needle in the arm.Gemcitabine and nab-paclitaxel are chemotherapy medications approved to treat this type of cancer. They both work by slowing down or stopping the growth of cancer cells. Both gemcitabine and nab-paclitaxel will be given by infusion into a vein.Patients can be enrolled on the study if they have not received treatment for their PDAC, and their PDAC has spread to other areas of their body. Around 610 patients will take part in this study at around 175 sites (around the globe). Assessments including ECGs, physical examinations, blood and urine collection, scans (CT or MRI) and completion of questionnaires will be performed. Patients will be randomly allocated to receive either Quemliclustat and chemotherapy, or placebo and chemotherapy. Treatment will continue for up to 2 years, after which time patients may continue to receive the chemotherapy treatment only.