Study of the Safety and Pharmacokinetics of XL765 (SAR245409) in Adults With Solid Tumors

Inclusion Criteria

• •The subject has a histologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival.
• •The subject has disease that is assessable by tumor marker, physical, or radiologic means.
• •The subject is at least 18 years old.
• •The subject's weight is at lease 40 kg.
• •The subject has an Eastern Cooperative Oncology Group performance status of 0 - 2.
• •The subject has adequate organ and bone marrow function.
• •The subject has fasting plasma glucose \< 120 mg/dL at screening.
• •for subjects who are to be enrolled into the Expanded MTD Cohort and Lower-Dose Tumor Genetic Alteration Subjects:
• •1. tumor tissue amenable to serial biopsy;
• •2. additional informed consent
• •The subject is capable of understanding the protocol and has signed the informed consent.
• •Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
• •Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
• •If the subject has received more than 3 prior regimens of cytotoxic chemotherapy, more than 2 biologic regimens, or more than 3000 cGy to \>25% of his or her bone marrow, the sponsor must determine subject suitability before enrollment.
• •The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥ 2 years ago, and has had no evidence of disease for 2 years prior to screening for this study.)