Safety Study of XL647 and XL147 Administered in Combination Daily in Adults With Solid Tumors

Exclusion Criteria

• •The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of XL647.
• •The subject has received prior treatment with a small molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days before the first dose of XL647.
• •The subject has received any other type of investigational agent within 30 days before the first dose of study treatment.
• •The subject has not recovered from toxicity due to prior therapy.
• •The subject has had major surgery within 30 days before the first dose of study drug. Subjects must have recovered or stabilized from prior surgery.
• •The subject is known to have diabetes.
• •The subject is currently receiving anticoagulation with warfarin (low-dose warfarin ≤ 1mg/day, heparin, and low-molecular weight heparins are permitted).
• •The subject has prothrombin time (PT)/International Normalized Ratio (INR) and /or partial thromboplastin time (PTT) test results at screening that are above 1.3 times the laboratory upper limit of normal.
• •The subject has any of the following cardiac criteria:
• •* Corrected QT interval (QTc) of \> 0.46 seconds
• •* Has a finding of left bundle branch block
• •* Has important bradycardia defined as a heart rate of \< 50 bpm due to sinus node dysfunction
• •* Has an obligate pacemaker
• •* History of sustained ventricular arrhythmias (subjects with a history of atrial arrhythmias should be discussed with the sponsor before entry into the study)
• •* Family history of congenital long QT syndrome or unexplained sudden death
• •* Has uncontrolled hypertension
• •* Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
• •The subject requires treatment with drugs known to be associated with torsades de pointes or significant QT interval prolongation.
• •The subject has a serum potassium level or a serum magnesium level that falls outside the normal range.
• •The subject has known brain metastases or a primary brain tumor.
• •The subject has intercurrent illness including but not limited to ongoing or active infection.
• •The subject is known to be positive for the human immunodeficiency virus (HIV).
• •The subject is pregnant or breastfeeding.
• •The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulations
• •The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee