Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma

Exclusion Criteria

• •The subject has previously been treated with a selective PI3K inhibitor, mTOR inhibitor, or AKT inhibitor.
• •The subject has uterine sarcomas (leiomyosarcoma), mixed Mullerian tumors, squamous carcinoma of the uterus, and/or adenosarcomas of the uterus.
• •Certain restrictions on prior treatments apply
• •The subject has not recovered from toxicity due to prior therapy to Grade ≤ 1 or to pre-therapy baseline (excluding alopecia and peripheral neuropathy).
• •The subject has a known primary brain tumor or brain metastasis.
• •The subject has any other diagnosis of malignancy or evidence of malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix) within 2 years before screening for this study.
• •The subject has a diagnosis of uncontrolled diabetes mellitus or has a fasting plasma glucose \> 160 mg/dL.
• •The subject is currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1 mg/day is permitted).
• •The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening that are above 1.3 x the laboratory upper limit of normal.
• •The subject has uncontrolled, significant intercurrent illness
• •The subject has a baseline corrected QT interval ≥ 470 ms.
• •The subject is known to be positive for the human immunodeficiency virus (HIV). (Note: Baseline HIV screening is not required.)
• •The subject is pregnant or breastfeeding.
• •The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation.