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