Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AEterna Zentaris
• Collaborator: AGO Study Group

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