Phase I Trial of Oral PX-866

Exclusion Criteria

• •Any active infection at study entry.
• •Known diabetes or fasting blood glucose\>160 mg/dL.
• •Known human immunodeficiency virus (HIV).
• •Any serious concomitant systemic disorders that in the opinion of the investigator would place the patient at excessive or unacceptable risk of toxicity.
• •Surgery within the four weeks prior to the first dose
• •Significant central nervous system (CNS) or psychiatric disorder(s) that preclude the ability of the patient to provide informed consent.
• •Known or suspected brain metastases that have not received adequate therapy or for which the patient requires treatment with steroids or anticonvulsants. In the case of previously treated brain metastases, a minimum four week interval between completion of radiation therapy and registration on study with radiologic evidence of stable or responding brain metastases is required. In the setting of previous CNS metastasectomy, adequate (minimum four week) recovery from surgery and/or radiation therapy should be documented.
• •Leptomeningeal brain metastases should be excluded regardless of whether the metastases have been treated or not.
• •History of seizures, non-healing wounds, or arterial thrombosis.
• •Unstable atrial or ventricular arrhythmias requiring control by medication; any cardiac ischemic event experienced within the preceding six months; prior history of congestive heart failure requiring therapy.
• •Breastfeeding or pregnant (confirmed by serum β-HCG within 10 days prior to the start of study treatment if applicable).
• •Total gastrectomy, partial bowel obstruction or any gastrointestinal condition that may interfere with absorption of the study medication.
• •Any condition that could jeopardize the safety of the patient and compliance with the protocol.