Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097409
Status:
COMPLETED
Last Update Posted:
2010-10-04
First Post:
2004-11-23
Brief Title:
Ispinesib In Subjects With Platinum-Taxane-Refractory Or Resistant Relapsed Ovarian Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Open-Label Study of Ispinesib in Subjects With PlatinumTaxane-Refractory or Resistant Relapsed Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2010-10
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:
The purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinumtaxane based chemotherapy and whose disease continues to progress The treatment involves a 1-hour treatment given intravenously IV and repeated once every 21 days A patient may continue to receive the treatment as long as they are benefiting from the treatment Blood samples will be taken at specific times over a 24 hour period to measure the amount of drug in your body at specific times after the drug is given Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries Physical exams will be performed before each treatment
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