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A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

Primary: To compare overall survival (OS) of patients with pre-treated, advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. OS is defined as the time from randomization until death from any cause. Secondary: To evaluate the safety profile of BBI608 administered daily plus weekly paclitaxel in patients with pre-treated advanced gastric/GEJ adenocarcinoma, with safety assessed according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. To compare Progression-Free Survival (PFS), defined as the time from randomization until the first objective observation of disease progression or death from any cause, in patients with pre-treated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. To compare the Objective Response Rate (OR), defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1 criteria, in patients with pre-treated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. To compare the Disease Control Rate (DCR), defined as the proportion of patients with a documented complete response, partial response and stable disease (CR + PR + SD) based on RECIST 1.1 criteria, in patients with pre-treated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. To explore the exposure/response relationships of BBI608 and paclitaxel in patients with pretreated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel using population pharmacokinetics with sparse PK sample collection. To explore an association between putative biomarkers as determined from paraffinembedded tumor specimens and the potential for clinical benefit in terms of overall survival, progression-free survival, disease control rate, and objective response rate, from treatment with BBI608 plus weekly paclitaxel in patients with pre-treated advanced gastric/GEJ adenocarcinoma. To explore associations with baseline values and changes of putative biomarkers (see Section 14.6) in the blood and the potential for clinical benefit in terms of overall survival, progression-free survival, disease control rate, and objective response rate, from treatment with BBI608 plus weekly paclitaxel in patients with pre-treated advanced gastric/GEJ adenocarcinoma. To compare the Quality of Life (QoL), as measured using the EORTC QLQ-C30, in patients with pre-treated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel.

Primary: To compare overall survival (OS) of patients with pre-treated, advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. OS is defined as the time from randomization until death from any cause. Secondary: To evaluate the safety profile of BBI608 administered daily plus weekly paclitaxel in patients with pre-treated advanced gastric/GEJ adenocarcinoma, with safety assessed according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. To compare Progression-Free Survival (PFS), defined as the time from randomization until the first objective observation of disease progression or death from any cause, in patients with pre-treated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. To compare the Objective Response Rate (OR), defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1 criteria, in patients with pre-treated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. To compare the Disease Control Rate (DCR), defined as the proportion of patients with a documented complete response, partial response and stable disease (CR + PR + SD) based on RECIST 1.1 criteria, in patients with pre-treated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. To explore the exposure/response relationships of BBI608 and paclitaxel in patients with pretreated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel using population pharmacokinetics with sparse PK sample collection. To explore an association between putative biomarkers as determined from paraffinembedded tumor specimens and the potential for clinical benefit in terms of overall survival, progression-free survival, disease control rate, and objective response rate, from treatment with BBI608 plus weekly paclitaxel in patients with pre-treated advanced gastric/GEJ adenocarcinoma. To explore associations with baseline values and changes of putative biomarkers (see Section 14.6) in the blood and the potential for clinical benefit in terms of overall survival, progression-free survival, disease control rate, and objective response rate, from treatment with BBI608 plus weekly paclitaxel in patients with pre-treated advanced gastric/GEJ adenocarcinoma. To compare the Quality of Life (QoL), as measured using the EORTC QLQ-C30, in patients with pre-treated advanced gastric/GEJ adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel.