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