Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00094003
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.
Study:
NCT00094003
Study Brief:
Protocol Section:
NCT00094003