Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094003
Status:
COMPLETED
Last Update Posted:
2005-11-11
First Post:
2004-10-08
Brief Title:
Study of NS-9 in Patients With Liver Metastases
Sponsor:
NS Pharma Inc
Organization:
NS Pharma Inc
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 IV 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None