Brief Title
Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors
Official Title
Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria
Secondary Outcome
Time-to-progression (TTP); Overall survival
Condition
Ovarian Cancer
Intervention
AEZS-108
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
85
Start Date
December 2007
Completion Date
July 2011
Primary Completion Date
July 2011
Eligibility Criteria
Inclusion Criteria:
- LHRH receptor positive tumor status: positive receptor status determined by
immunohistochemistry from primary tumor
- Histologically confirmed epithelial ovarian cancer (Stratum A)
- Advanced (FIGO III or IV) or recurrent disease
- Progression during treatment with a platinum-based regimen or within 6 months after
receiving a platinum-based regimen
- Previous treatment with a taxane-containing regimen
- At least one measurable target lesion (RECIST criteria) OR CA125 level higher than
twice the upper limit of normal range (GCIG criteria)
- Histologically confirmed endometrial cancer (Stratum B)
- Advanced (FIGO III or IV) or recurrent disease not amenable to potentially curative
treatment with local surgery and/or radiation therapy
- No previous anthracycline-based chemotherapy
- At least one measurable target lesion according to RECIST criteria
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Günter Emons, Prof.Dr.med., ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT00569257
Organization ID
AEZS-108-040
Secondary IDs
AGO-GYN 5
Responsible Party
Sponsor
Study Sponsor
AEterna Zentaris
Collaborators
AGO Study Group
Study Sponsor
Günter Emons, Prof.Dr.med., Principal Investigator, Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen
Verification Date
December 2011