Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350948
Status:
TERMINATED
Last Update Posted:
2013-11-27
First Post:
2006-07-06
Brief Title:
Phase 3 Randomized Study of Telcyta Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
Sponsor:
Telik
Organization:
Telik
Study Overview
Official Title:
Phase 3 Randomized Study of TLK286 Telcyta in Combination With Liposomal Doxorubicin DoxilCaelyxVersus Liposomal Doxorubicin DoxilCaelyx as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer ASSIST-5
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSIST-5
Brief Summary:
The purpose of this research study is to determine if Telcyta given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy
Detailed Description:
This is a randomized open label multicenter multinational Phase 3 study of TLK286 Telcyta in combination with liposomal doxorubicin DoxilCaelyx as compared to the active control therapy with liposomal doxorubicin DoxilCaelyx as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer Patients will be randomly assigned to receive either TLK286 Telcyta in combination with liposomal doxorubicin DoxilCaelyx or active control liposomal doxorubicin DoxilCaelyx
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