Inclusion Criteria:

A patient must meet the following criteria to be eligible for study entry:

• Histologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen. Patients must not be candidates for regimens known to provide clinical benefit.
• Evaluable or measurable disease per RECIST
• Life expectancy of ≥ 12 weeks
• Documented willingness to use an effective means of contraception for both men and women while participating in the study

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry:

• Leptomeningeal disease as the only manifestation of the current malignancy
• History of Type 1 or 2 diabetes mellitus requiring regular medication
• Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytics
• Malabsorption syndrome or other condition that would interfere with enteral absorption
• Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months
• Active congestive heart failure or ventricular arrhythmia requiring medication
• Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
• Active infection requiring intravenous (IV) antibiotics
• Patients requiring any daily supplemental oxygen
• Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN) or hypercalcemia above the ULN for the institution despite adequate electrolyte supplementation or management
• Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• Known human immunodeficiency virus (HIV) infection
• Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
• Significant traumatic injury within 3 weeks before Day 1
• Major surgical procedure within 4 weeks prior to initiation of study treatment
• Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
• Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
• Need for chronic corticosteroid therapy for > 7 days