E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epithelial Ovarian Cancer |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the benefit in terms of recurrence free survival (RFS) of Abagovomab vs placebo as maintenance therapy after clinical complete response to debulking surgery and standard platinum/taxane 1st line chemotherapy. |
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E.2.2 | Secondary objectives of the trial |
1) To compare the effect of Abagovomab vs placebo in terms of overall survival(OS) 2) To evaluate the safety and tolerability of repeated doses of Abagovomab 3) To evaluate the time course of immune response induced by repeated doses of Abagovomab, namely induction of Ab3 and HAMA 4) To evaluate in a subsect of approximately 10% of patients additional immunologic parameters (i.e. Ab1 and CA125-specific T cell response) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At a maximum of 12 weeks after the last cycle of first line IV or IP standard platinum/taxane chemotherapy,patients must fulfil all the following inclusion criteria to be eligible for entry in to study; 1) Age ≥ 18 years; 2) Properly executed written informed consent; 3) History of histological and CA125 (>35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian,fallopian tube,or primary peritoneal cancer; 4) History of debulking surgery and of 6-8 cycles of standard platinum/taxane based non-investigational IV/IP chemotherapy; 5) Complete clinical response defined as; - Normal Physical examination; - No symptoms suggestive of persistent cancer; - No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks; - Negative chest x-ray (or chest CT scan) within the previous 4 weeks; - Serum CA 125 level within normal laboratory range. 6) Adequate hematologica,renal and hepatic function: - ANC ≥ 1.5 x 10(9)/l; - Platelets ≥ 75 x 10(9)/l; - Haemoglobin ≥ 6.2 mmol/l (≥ 9.9 g/dl); - Serum creatinine ≤ 1.5 x ULN; - Bilirubin ≤ 1.5 x ULN, AST, ALT, AP ≤ 2.5 x ULN. 7) ECOG performance status (PS) ≤ 2. |
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E.4 | Principal exclusion criteria |
Patients are ineligible to participate in the study, if any of the following criteria are present: 1) Any other invasive malignancies, with the exception of non melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy; 2) Known active autoimmune disease requiring chronic treatment with immunosuppressive agents(e.g. rheumatoid arthritis, ulcerative colitis,etc.); 3) Known immune deficiency (e.g. HIV,hypogammaglobulinemia,etc.) 4) Known infection with hepatitis B, or hepatitis C; 5) History of recent myocardial infarction (≤ 6 months) or decompensated heart failure(NYHA class ≥ III); 6) Previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front-line chemotherapy 7) Concomitant use of any other Investigational agent; 8) Any prior investigational anti-cancer vaccine or monoclonal antibody; 9) Known allergy to murine proteins; 10) Any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures; 11) Major surgery within the previous 2 weeks; 12) Radiotherapy within the previous 4 weeks; 13) Any significant toxicity from prior chemotherapy; 14) Unreliability or inability to follow protocol requirements 15) Potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period 16) Pregnancy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Recurrence Free Survival (i.e. time from the date of randomization to documentation of disease recurrence or death from any cause). |
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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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 105 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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Treatment will end 21 months from the randomization of the last patient, and the DBO period will end 12 weeks after the last administered dose, i.e. 24 months from the randomization of the last patient. At that time all patients on study will undergo a final study visit. Survival status will continue to be followed (open) up to 5 years after the end of DBO period. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |