A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen

Exclusion Criteria

• •* Progressive disease after at least 1 hormonal treatment with documented testosterone levels less than 50 ng/dl
• •* Concurrent use of an agent for testosterone suppression (e.g., luteinizing hormone-releasing hormone \[LHRH\] agonist) is required if the participants has not been surgically castrated
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• •Recovered to less than or equal to Grade 1 toxicity (CTCAE), to participant's baseline status (except alopecia) or deemed irreversible from the effects of prior cancer therapy and must have evidence of progressive or persistent disease
• •Adequate bone marrow, liver and renal function
• •Any use of opiates must be stable for at least 2 weeks prior to study entry
• •Female participants who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time
• •Male participants who agree to practice effective barrier contraception during the entire study and through 6 months after the last dose of study drug OR agree to abstain from heterosexual intercourse
• •Voluntary written consent
• •Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
• •Suitable venous access for blood sampling
• •Female participants who are lactating or pregnant
• •Antineoplastic therapy or any experimental therapy within 21 days before the first dose of alisertib
• •Prior or current investigational therapies within 4 weeks before the first dose of MLN8237
• •Concurrent investigational treatment of treatment with any investigational products within 28 days before the first dose of alisertib
• •Radiotherapy to greater than 40% of bone marrow or any radiotherapy (except localized, small field radiation) within 4 weeks prior to enrollment, unless reviewed and approved by the medical monitor
• •Nitrosoureas or mitomycin-C within 6 weeks before the first dose of alisertib.
• •Autologous stem cell transplant within 3 months before the first dose of alisetib, or prior allogeneic stem cell transplant at any time.
• •Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of alisertib
• •For CRPC participants:
• •* Radiotherapy or antiandrogen therapy for prostate cancer within 4 weeks prior to enrollment
• •* Prior treatment with antineoplastic chemotherapy or radioisotopes for advanced prostate cancer
• •* Use of products known to affect PSA levels within 4 weeks of enrollment
• •Major surgery within 4 weeks of study enrollment
• •Uncontrolled high blood pressure
• •Participants with abnormal gastric or bowel function or who require continuous treatment with antacids or proton pump inhibitors
• •Participants receiving chronic steroid therapy other than the following: low dose steroid for the control of nausea and vomiting, topical steroid, inhaled steroid or use of dexamethasone
• •Known severe hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
• •Comorbid condition or unresolved toxicity that would preclude administration of docetaxel
• •Prior history of Grade 2 or greater neurotoxicity or any toxicity that has not resolved to Grade 1 or below
• •Symptomatic brain or other CNS metastasis
• •Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
• •Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
• •Participants requiring full systemic anticoagulation
• •Prior allogeneic bone marrow or other organ transplant
• •Active infection requiring systemic therapy within 14 days preceding first dose, or other serious infection
• •History of hemorrhagic or thrombotic cerebrovascular event in the past 12 months
• •Serious medical or psychiatric illness that could interfere with protocol completion
• •Inability to swallow oral medication
• •Prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
• •Prior treatment with more than 1 prior taxane-containing regimen