Oral NRX 194204 Study in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Exclusion Criteria

• •Significant medical history or unstable medical condition (congestive heart failure, recent myocardial infarction within 3 months, unstable angina, active systemic infection, uncontrolled hypertension). Patients with controlled diabetes will be allowed.
• •Prior treatment with bexarotene (Targretin) or NRX 194204.
• •Current enrollment in an investigational drug or device study or participation in such a study within 21 days of entry into this study.
• •Known sensitivity to any of the ingredients in the study medication.
• •Known HIV-positive patients.
• •Females who are pregnant, nursing, or planning a pregnancy.
• •Major surgery within previous 4 weeks; large field radiation therapy (\> 25% of the patient's total marrow) or chemotherapy (including investigational agents or participation in another clinical study) within previous 3 weeks; mitomycin C or nitrosoureas within 6 weeks. In all instances, patients must have fully recovered from acute toxicities related to prior therapies.
• •Systemic retinoid therapy, or Vitamin A at dosages \> 15,000 IU per day, during previous 4 weeks.
• •Patients with a history of pancreatitis or at significant risk of developing pancreatitis (e.g., uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity).
• •Primary brain tumors, active brain metastasis including progression from last scan or evidence of cerebral edema, or clinical symptoms of brain metastasis.
• •Condition or situation which, in the investigator's opinion, may put patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study.