Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 34
- Primary Endpoint
- Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria
Time Frame: up to six 3-weekly treatment cycles
Secondary Outcomes
- Time-to-progression (TTP); Overall survival(up to observation of event)
- Safety of AEZS-108 (possibly drug-related adverse events)(4 weeks beyond last drug admnistration)