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

Inclusion Criteria:

Each participant must meet all of the following inclusion criteria to be enrolled in the study:

18 years or older
Histologically or cytologically confirmed advanced tumors and candidates for docetaxel treatment
Measurable or evaluable disease is required. Participants must have clinical evidence of progressive disease or persistent disease

Participants with castration-resistant prostate cancer (CRPC) are required to have

Pathologically confirmed adenocarcinoma of the prostate
Evidence of metastatic disease on bone scan or other imaging. Participants with prostate-specific antigen (PSA) elevation as the only manifestation of disease are not eligible.
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

Exclusion Criteria:

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:

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