A Study of NK012 in Patients With Relapsed Small Cell Lung Cancer

Exclusion Criteria

• •1. Patient has Gilbert's Syndrome.
• •2. Prior chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
• •3. Lack of recovery from adverse effects due to agents administered more than 4 weeks prior to study entry.
• •4. Concurrent use of other investigational agent.
• •5. History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for \> 1 week.
• •6. Prior exposure to topoisomerase 1 inhibitors (i.e., irinotecan, topotecan, camptothecin).
• •7. Concurrent serious infections requiring parenteral therapy.
• •8. Pregnant or of childbearing potential and not using methods to avoid pregnancy. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breast-feed infants while on this study.
• •9. Significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias or poorly controlled angina.
• •10. History of serious ventricular arrhythmia (VT or VF, greater than or equal to 3 beats in a row), QTc greater than or equal to 450 msec for men and 470 msec for women, or LVEF less than or equal to 40% by MUGA or ECHO.