Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 7:54 AM
Study NCT ID:
NCT00569257
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2007-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors
Sponsor:
AEterna Zentaris
Organization:
Study Overview
Official Title:
Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors
Status:
COMPLETED
Status Verified Date:
2011-12
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 whether AEZS-108 shows anti-tumor activity and is tolerated in patients with gynecological tumors (ovarian / endometrial cancer) that have been shown to express receptors for the luteinizing hormone releasing hormone (LHRH)
Detailed Description:
The ovary and the endometrium are hormone dependent organs. Receptors for different sex hormones are found commonly in epithelial ovarian and endometrial cancers. LHRH and its receptors are expressed in about 80% of human ovarian and endometrial cancers. As binding sites are present on tumors in higher concentrations than on most normal tissues, these receptors represent a specific target for AEZS-108 in which doxorubicin is coupled to an LHRH analog.
Patients whose tumor specimen have shown to be positive for LHRH receptor expression will be investigated for tumor response and tolerability.
Patients whose tumor specimen have shown to be positive for LHRH receptor expression will be investigated for tumor response and tolerability.
Study Oversight
Has Oversight DMC:
False
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?: