A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Ad

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 weekly 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.

November 10, 2017

  • Clinical Trial Information

    Trial Contact: Larney, Patricia; Jobson, Gillian S

    Trial Phone: 321-841-2042 ; 321.841.2285

  • Age Group: Adult

    Phase: Drug: Phase III

    Principal Investigator: Omar R. Kayaleh, MD

    Sub Investigators:

    IRB No:

    Secondary Protocol No: CanStem 111P

    Applicable Disease Sites: Carcinoma, Pancreatic Ductal