Clinical trial · Interventional
Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors
Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors
NCT00569257CI-TRIAL-00005921completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEZS-108 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria
- timeFrame
- up to six 3-weekly treatment cycles
Secondary outcomes (2)
- measure
- Time-to-progression (TTP); Overall survival
- timeFrame
- up to observation of event
- measure
- Safety of AEZS-108 (possibly drug-related adverse events)
- timeFrame
- 4 weeks beyond last drug admnistration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.