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A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers

Phase 1
18 Years
Not Enrolling
Liver Neoplasms, Neoplasm Metastasis, Local Neoplasm Recurrences

Thank you

Trial Information

A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers

This study requires subjects to undergo 2 treatment cycles of NS-9. Each cycle consists of
once daily, 1-hour I.V. infusions of the drug for 5 days followed by a 23-day rest period.
During the rest period, subjects are seen at the clinic once weekly for evaluation.
Subjects having favorable or stable results after 2 cycles may continue to receive NS-9 in
the extension phase of the study until the disease progresses or until they get a side
effect that prevents them from continuing with therapy.

After each two cycles, if appropriate, the liver tumor will be measured by radiologic
imaging to compare it to its pre-treatment size.

Inclusion Criteria:

- 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

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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

September 2002

Completion Date:

Related Keywords:

  • Liver Neoplasms
  • Neoplasm Metastasis
  • Local Neoplasm Recurrences
  • Liver metastases
  • Colorectal cancer
  • Gastric cancer
  • Esophagus cancer
  • Breast cancer
  • Lung cancer
  • Skin cancer
  • Renal Cancer
  • Liver metastasis
  • Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Neoplasm Recurrence, Local
  • Recurrence



MD Anderson Cancer Center Houston, Texas  77030-4096
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756