Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

Exclusion criteria

• ✕. Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
• ✕. Major surgery within 28 days or serious infection requiring IV antibiotics within 14 days preceding the first dose of study treatment.
• ✕. Patient has received other investigational drugs within 14 days before enrollment.
• ✕. Known GI disease or GI procedure that could impact drug absorption in the upper bowel, or tolerance of Alisertib. Examples include but are not limited to partial gastrectomy, small bowel resection, pancreatectomy, malabsorption or celiac disease.
• ✕. Patient requires constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed (to manage gastric acidity or reflux) during the study day 8 - 20. \[Histamine-2 (H2) receptor antagonists are not permitted from the day prior (Day -1) through to the end of Alisertib dosing (Day 7)\]
• ✕. Ongoing nausea or vomiting of any severity without improvement after appropriate treatment.
• ✕. \> Grade 1 diarrhea, not controlled with appropriate treatment.
• ✕. History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease requiring supplemental oxygen.