A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer

Exclusion Criteria

• •CNS metastases by radiologic evidence or histology, unless clinically stable (must have been treated by resection or radiation) for at least 4 weeks prior to first dose of study drug. Patients may not be receiving dexamethasone for control of CSF pressure.
• •Concurrent therapeutic anticoagulation: PTT less than or equal to 1.5 × ULN or low dose aspirin and low-weight heparin only are allowed.
• •More than 2 previous lines of chemotherapy for lung cancer. This includes biologic (immunotherapy) therapy.
• •History of previous cerebrovascular accident (CVA) or history transient ischemic attack (TIA) within 6 months of study entry.
• •History of prior malignancy not cured by excision. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least 2-year disease free interval.
• •Recent history (within 6 months of screening) of unstable angina, myocardial infarction, or NYHA Class III or IV congestive heart failure
• •History of cardiac arrhythmia requiring medical or electrical therapy.
• •QTc \> 450 msec for males and \> 470 msec for females.
• •Any major surgery within 30 days or minor surgery within 10 days of study entry, or patient not recovered from surgery.
• •History of organ or bone marrow transplant.
• •Known active and/or uncontrolled infection, including HIV and are not stable on antiretroviral therapy.
• •Any investigational therapy within 28 days of study entry.
• •Pregnant or nursing.
• •Anyone who in the judgment of the investigator cannot comply with the protocol, provide truly informed consent, or is likely to live \< 90 days
• •Severe or significant allergy to any chemotherapy or premedication.
• •Clinically evident ascites (e.g., abdominal distention, bulging and/or fluid wave) or Grade 3 peripheral edema.
• •Any prior cancer treatment with a topoisomerase I inhibitor.