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

Inclusion Criteria
Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic
Must not have previously received chemotherapy or any investigational agent for the treatment of metastatic PDAC
Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator
Patient has one or more metastatic tumors evaluable by CT scan with contrast Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, assessed within 14 days prior to randomization
Must have life-expectancy of > 12 weeks
Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization
The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.
Exclusion Criteria
Patients with no evidence of metastatic disease as well as patients with a local recurrence following surgical resection of primary lesion
Patient has experienced a decline in ECOG performance status between Baseline visit and within 72 hours prior to randomization
Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC
Major surgery within 4 weeks prior to randomization
Any known brain or leptomeningeal metastases are excluded, even if treated.
Patients with clinically significant ascites
Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin or while undergoing treatment with nab-paclitaxel and gemcitabine and for 180 days after the last dose of nab-paclitaxel and gemcitabine
Gastrointestinal disorder(s) which, in the opinion of the Principal Investigator, would significantly impede the absorption of an oral agent (e.g. active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
Unable or unwilling to swallow napabucasin capsules daily
Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
Known hypersensitivity to gemcitabine, taxanes or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Summary of Product Characteristics or Prescribing Information
Neurosensory neuropathy > grade 2 at baseline
Uncontrolled chronic diarrhea > grade 2 at baseline
Patients being treated with Warfarin
Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy
Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated by surgery alone or surgery plus radiotherapy with no evidence of disease continuously for > 5 years
Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy. 20. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol, including patients with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol. Patients planning to take a vacation for 14 or more consecutive days during the course of the study are ineligible.