Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477282
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2007-05-21
Brief Title:
Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer
Sponsor:
BioNumerik Pharmaceuticals Inc
Organization:
BioNumerik Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Study of Safety and Efficacy of Karenitecin Versus Topotecan Administered for 5 Consecutive Days Every 3 Weeks in Patients With Advanced Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinumtaxane-resistant advanced epithelial ovarian cancer Additionally this study will assess the ability of karenitecin to extend the time to disease progression extend the overall survival time and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer
Detailed Description:
None
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