Study of NK012 in Patients With Refractory Solid Tumors

Exclusion Criteria

• •Have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse effects due to agents administered more than 4 weeks earlier
• •Receiving any other investigational agent
• •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
• •History of allergic reactions attributed to compounds of similar chemical composition to NK012
• •Concurrent serious infections (i.e., requiring an intravenous antibiotic)
• •Pregnant women or women of childbearing potential who are not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline and before every NK012 administration for women of childbearing potential; no breast-feeding while on study
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements
• •Significant cardiac disease
• •History of serious ventricular arrhythmia
• •Positive for anti-HbsAg, anti-HCV, anti-HIV, or anti-syphilis antibodies