Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246688
Status:
COMPLETED
Last Update Posted:
2015-12-31
First Post:
2005-10-28
Brief Title:
Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Randomized Multicenter Prospective Two-arm Open-label Phase II Study to Investigate the Efficacy and Safety of Two ZK219477 iv Infusions 3-hour Infusion of 16mgm2 Versus 05-hour Infusion of 16 mgm2 in Patients With Recurrent Ovarian Cancer Progressing During or Within 6 Months of the End of Platinum-based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-12
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 purpose of this study is to determine if this epothilone leads to a response in patients with recurrent ovarian cancer that has progressed during or in the last six months since a treatment of platinum-based chemotherapy We also aim to look at the safety of the study drug and assess the impact of the infusion duration on tolerability
Detailed Description:
The study has previously been posted by Schering AG Germany Schering AG Germany has been renamed to Bayer Schering Pharma AG GermanyBayer Schering Pharma AG Germany is the sponsor of the trial
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-000635-15 | EUDRACT_NUMBER | None | None |
| 307970 | EudraCT Number | None | None |