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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
NS9001
NCT00094003
September 2002
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |