Study of NS-9 in Patients With Liver Metastases

Exclusion Criteria

• •Subject is mentally or legally incapacitated, or has significant emotional or psychiatric problems.
• •Concomitant primary malignant and/or non-malignant liver disease (primary liver cancer, acute or chronic hepatitis, cirrhosis, alcoholic liver disease).
• •History of pancreatic disease (e.g., pancreatitis, pancreatic malignancy).
• •New York Heart Association classification Class III or IV
• •Uncontrolled intercurrent illnesses including but not limited to: hypertension, seizure disorder, renal, gastrointestinal, or hematological diseases.
• •Clinically relevant systemic disease (other than the malignancy and malignancy-related hepatic dysfunction) making implementation of the protocol or interpretation of the study results difficult.
• •Pregnant or nursing, or unwilling to or will not agree to use an effective and reliable contraceptive measure.
• •Subject has received radiation to \>25% of the total bone marrow.
• •Subject has a history of any other illness that would preclude study participation.
• •Subject has brain metastases.
• •Subject has allergy to egg yolk.
• •Subject receiving low-molecular weight heparin for treatment of a blood coagulation disorder (e.g., deep vein thrombosis, pulmonary embolism).