A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers
- Male and female at least 18 years of age.
- Patients with liver metastases from various primary cancers for which no other
curative treatment options exist.
- At least one measurable lesion (by CT or MRI)
- Life expectancy > 3 months
- Child-bearing potential women must have a negative serum pregnancy test
- ECOG performance status: 0-1
- Fully recovered from any previous cancer therapy or infection (at least 4 weeks from
radiation or chemotherapy, at least 3 weeks from a major surgical procedure and at
least 2 weeks from an exploration/biopsy)
- Discontinued from any other investigational drug for at least 30 days
- Serum calcium <11 mg/dL
- Absolute neutrophil count (ANC) ≥1,500/mm3, without growth factor support
- Hemoglobin ≥9.0 g/dL
- Platelet count ≥100,000/mm3
- Serum creatinine ≤1.5 times the upper limit of normal (ULN)
- Bilirubin ≤1.5 times ULN
- ALT and AST ≤3 times ULN
- Amylase and lipase ≤ ULN
- PT and PTT < 1.5 times ULN
- ECG with no acute abnormalities
- Afebrile (≤37.5C or 99.5F)
- Willingness and ability to comply with all study requirements
- Subject is mentally or legally incapacitated, or has significant emotional or
- 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).