Study of NS-9 in Patients With Liver Metastases

Completed · Phase 1

Conditions studied: Liver Neoplasms, Neoplasm Metastasis, Local Neoplasm Recurrences

In brief

This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.

Key facts

Study ID

NCT00094003

Run by

NS Pharma, Inc.

People needed

20

Starts

2002-09-01

Last updated by the study team

2005-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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