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

About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Hematology Oncology Associates of the Treasure Coast
- University of Chicago
- Carle Cancer Center
- Massachusetts General Hospital
- Wayne University, Wertz Clinical Cancer Center, Karmanos Center
- Memorial Sloan Kettering Cancer Center
- Case Western Reserve University, University Hospitals of Cleveland
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
Patients received XL647 at an intermittent dosing schedule receiving drug for 5 days followed by 9 days without drug.
Patients received drug at a daily dosing schedule