E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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; positive receptor status determined by immunohistochemistry from primary tumor |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007069 |
E.1.2 | Term | Cancer of endometrium stage III |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007065 |
E.1.2 | Term | Cancer of endometrium recurrent |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007070 |
E.1.2 | Term | Cancer of endometrium stage IV |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057529 |
E.1.2 | Term | Ovarian cancer metastatic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066697 |
E.1.2 | Term | Ovarian cancer recurrent |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To assess partial or complete tumor response rate according to RECIST and/or GCIG guidelines
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E.2.2 | Secondary objectives of the trial |
1. To assess time to progression; survival 2. To assess toxicity / adverse effects |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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) < 60%. 4) Prior radiotherapy to the pericardial area > 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: < 100x109/L; - absolute neutrophil count (ANC): < 1.5x109/L; - hemoglobin: < 6.8 mmol/L (< 11 g/100 mL); - ASAT, ALAT, AP: > 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
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |