Histologically confirmed malignancy of ovary or endometrium that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective and LHRH receptor positive tumor status
Conditions
Interventions
Product Name: n.a.
Product Code: AEZS-108
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 139570-93-7
Current Sponsor code: AEZS-108
Concentration unit: mg milligram(s)
Concentration
Sponsors
AEterna Zentaris GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Woman = 18 years of age 2) LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor 3) Stratum A - ovarian cancer: • Histologically confirmed epithelial ovarian cancer • Advanced stage: 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 • No previous anthracycline-based chemotherapy and not more than 2 previous chemotherapies or cytostatic therapies • At least one measurable target lesion (RECIST criteria) OR CA125 level higher than twice the upper limit of normal range (GCIG criteria) 4) Stratum B - endometrium cancer: • Histologically confirmed endometrial cancer • Advanced (FIGO III or IV) or recurrent disease • No previous anthracycline-based chemotherapy • Previous endocrine therapy is allowed • At least one measurable target lesion according to RECIST criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) History of allergic reaction to anthracycline or peptide drugs or to protein. 2) Patients with a history of unstable or newly diagnosed angina pectoris, documented history or current serious arrhythmia or CHF or recent myocardial infarction (within 6 months of enrolment). 3) Left ventricular ejection fraction (LVEF) 35 Gy and more than 50% of bone marrow involved 5) Concomitant use of potentially cardiotoxic medication (e.g. calcium channel entry blockers). 6) Chemo-, immune-, hormone-, or radiotherapy within 4 weeks prior to entry (nitrosoureas or mitomycin C: 6 weeks). 7) Any non-compensated or uncontrolled non-malignant condition, such as active tuberculosis or any other active infection. 8) Any of the following laboratory values: - thrombocyte count: 2.5 times upper limit of normal range (ULN): (> 5x ULN if clearly related to liver metastases); - creatinine, bilirubin: > ULN. 9) Lactating female or female of child-bearing potential not employing adequate contraception. 10) Brain metastasis, leptomeningeal disease. 11) ECOG performance > 2. 12) Life expectancy < 3 months. 13) Neurological or psychiatric disease or drug or alcohol abuse which would interfere with the subjects’ proper completion of the protocol assignment. 14) Use of LHRH agonist or antagonist treatment within 6 months prior to entry. 15) Concomitant or recent (within 8 weeks) treatment with other investigational drug; or prior treatment with AEZS-108 (at any time) 16) Ovarian cancer patients without initial measurable disease must not have received mouse antibodies (unless the CA 125 assay used has been shown not to be influenced by human antimouse antibodies (HAMA)) AND 17) not have had surgical or medical manipulation of their peritoneal or pleural cavity within 4 weeks preceding their screening for initial CA 125
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess partial or complete tumor response rate according to RECIST and/or GCIG guidelines ;Secondary Objective: 1. To assess time to progression; survival 2. To assess toxicity / adverse effects;Primary end point(s): Efficacy: Tumor response | — |
Countries
Bulgaria, Germany
Outcome results
None listed