Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 11:17 PM
Study NCT ID:
NCT00094003
Status:
COMPLETED
Last Update Posted:
2005-11-11
First Post:
2004-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NS-9 in Patients With Liver Metastases
Sponsor:
NS Pharma, Inc.
Organization:
Study Overview
Official Title:
A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
After each two cycles, if appropriate, the liver tumor will be measured by radiologic imaging to compare it to its pre-treatment size.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: