A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Combination With Paclitaxel and Carboplatin in Subjects With Solid Tumors

Inclusion Criteria:

- Confirmed diagnosis of:

- Advanced solid tumor that is no longer responding to therapies OR

- Advanced or recurrent endometrial carcinoma OR

- Advanced or recurrent ovarian carcinoma OR

- Unresectable (Stage IIIB or IV) NSCLC

- ECOG Performance Status 0-1 (ECOG status of 2 may be considered following discussion
and agreement with sponsor)

- Adequate organ and bone marrow function as defined by hematological and serum
chemistry limits

- At least 18 years old

- Both men and women must practice adequate contraception

- Informed consent

Exclusion Criteria:

- Restriction of some therapies/medications within specific timeframes prior to
enrollment and during the study including prior therapy with PI3K, AKT, or mTOR
inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C,
small-molecule kinase inhibitors, non-cytotoxic hormonal agents

- Known allergy or hypersensitivity to any of the components of the treatment
formulations

- Taking oral corticosteroids chronically or > 1 mg/day warfarin

- Not recovered from the toxic effects of prior therapy

- History of diabetes mellitus.

- Uncontrolled intercurrent illness

- Pregnant or breastfeeding

- Congestive heart failure, unstable angina, or a myocardial infarction within 3 months
of entering the study.

- HIV positive

- Diagnosis of another malignancy may exclude subject from study