Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT00032903
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2002-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.
Sponsor:
Sigma-Tau Research, Inc.
Organization:
Study Overview
Official Title:
Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial
Status:
COMPLETED
Status Verified Date:
2009-06
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:
Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.
Detailed Description:
None
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?: