Study of XL281 in Adults With Solid Tumors

Exclusion Criteria

• •The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug.
• •The subject has received treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within a certain amount of time before the first dose of study drug.
• •The subject has received any other investigational agent within 28 days of first dose of XL281.
• •The subject has not recovered to Grade ≤1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 30 days prior to study enrollment. Some irreversible toxicities from previous treatment may be allowed.
• •The subject requires treatment with antacids (continual treatment), proton pump inhibitors, or H2 receptor antagonists.
• •The subject has a primary brain tumor or known brain metastases.
• •The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •The subject is pregnant or breastfeeding.
• •The subject is known to be positive for the human immunodeficiency virus (HIV).
• •The subject has an allergy or hypersensitivity to components of the XL281 formulation or to famotidine.
• •The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
• •The subject is receiving anticoagulation with warfarin or coumarin-related compounds (low-dose warfarin ≤ 1 mg/day, heparin, and low-molecular weight heparin are permitted)
• •The subject must meet certain other eligibility requirements.