Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer

Exclusion Criteria

• •Prior treatment with any cytotoxic chemotherapy except as an adjuvant therapy. Participant should not have received gemcitabine within 6 months of starting the study treatment. 5-Fluorouracil or radiation treatment should be received more than 4 weeks prior to receiving the study drug.
• •May not be receiving any other investigational agents within 4 weeks of starting the study treatment and during the study period.
• •Untreated brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel or enzalutamide.
• •Have undergone major surgery within 4 weeks prior to starting the study treatment.
• •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; history of myocardial infarction within 6 months of starting study treatment.
• •Known history of human immunodeficiency virus (HIV) infection or active hepatitis B or hepatitis C
• •Any history of seizure. History of loss of consciousness or transient ischemic attack within 12 months of starting the study drug.
• •Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control
• •Chronic treatment with immunosuppressant drugs
• •Other malignancy requiring active treatment
• •Any significant medical condition, laboratory abnormality, or psychiatric illness, that would prevent participating in the study, including the inability to swallow capsules
• •Any active infection not controlled by antibiotics
• •Concomitant medications that lower seizure threshold