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A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Primary Objective: To compare overall survival (OS) of patients with metastatic pancreatic adenocarcinoma (PDAC) treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine (Arm 1) versus weekly nab-paclitaxel with gemcitabine (Arm 2). Secondary Objectives: To compare OS in patients treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine (Arm 1) versus nab-paclitaxel with gemcitabine (Arm 2) in biomarker positive PDAC patients. To compare Progression-Free Survival (PFS) in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. To compare PFS in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine in biomarker positive patients. To compare Overall Response Rate (ORR) and Disease Control Rate (DCR) in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. To compare ORR and DCR in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine in biomarker positive patients. To evaluate the safety profile of BBI-608 administered daily plus weekly nab-paclitaxel and gemcitabine in patients with metastatic PDAC with safety assessed according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0. To compare the Quality of Life (QoL), as measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30), in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.

Primary Objective: To compare overall survival (OS) of patients with metastatic pancreatic adenocarcinoma (PDAC) treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine (Arm 1) versus weekly nab-paclitaxel with gemcitabine (Arm 2). Secondary Objectives: To compare OS in patients treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine (Arm 1) versus nab-paclitaxel with gemcitabine (Arm 2) in biomarker positive PDAC patients. To compare Progression-Free Survival (PFS) in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. To compare PFS in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine in biomarker positive patients. To compare Overall Response Rate (ORR) and Disease Control Rate (DCR) in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. To compare ORR and DCR in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine in biomarker positive patients. To evaluate the safety profile of BBI-608 administered daily plus weekly nab-paclitaxel and gemcitabine in patients with metastatic PDAC with safety assessed according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0. To compare the Quality of Life (QoL), as measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30), in patients with metastatic PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.