Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

Inclusion criteria

• Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
• Measurable disease defined according to RECIST
• ECOG performance status of 0 or 1
• Normal organ and marrow function
• No other malignancies within 5 years, except for non-melanoma skin cancer

Exclusion criteria

• Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
• Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
• Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered > 30 days before study enrollment
• Receiving anticoagulation therapy with warfarin (low-dose warfarin < 1 mg/day, heparin and low molecular weight heparins are permitted)
• The subject meets any of the following cardiac criteria:

• Corrected QT interval (QTc) of > 460 msec
• Family history of congenital long QT syndrome or unexplained sudden death
• History of sustained ventricular arrhythmias
• Has a finding of left bundle branch block
• Has an obligate pacemaker
• Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node dysfunction
• Has uncontrolled hypertension
• Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
• Has a serum potassium or serum magnesium level that falls outside the normal range
• The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
• Uncontrolled intercurrent illness
• Subject is pregnant or breastfeeding
• Known HIV