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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061328 |
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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 subset 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 | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
At a maximum of 8 weeks after the last cycle of 1st line standard platinum/taxane chemotherapy, patients must fulfil all the following inclusion criteria to be eligible for entry into the study 61607; Age 18 years; 61607; Properly executed written informed consent; 61607; History of histological and CA125 35 U/ml confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; 61607; History of debulking surgery and standard platinum/taxane based non-investigational chemotherapy; 61607; Complete clinical response defined as 61692; Normal physical examination; 61692; No symptoms suggestive of persistent cancer; 61692; No definite evidence of disease by computed tomography CT of the abdomen and pelvis within the previous 4 weeks; 61692; Negative chest x-ray or chest CT scan within the previous 4 weeks; 61692; Serum CA125 level 35 U/ml. 61607; Adequate hematologic, renal and hepatic function 61692; ANC 1.5 x 109/l; 61692; Platelets 75 x 109/l; 61692; Haemoglobin 6.2 mmol/l 9.9 mg/dl ; 61692; Serum creatinine 1.5 x ULN; 61692; Bilirubin 1.5 x ULN; AST, ALT, AP 2.5 x ULN. 61607; 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 61607; 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; 61607; known active autoimmune disease requiring chronic treatment with immunosuppressive agents e.g., rheumatoid arthritis, ulcerative colitis, etc. ; 61607; known immune deficiency e.g. HIV, hypogammaglobulinemia, etc. ; 61607; known infection with hepatitis B, or hepatitis C; 61607; history of recent myocardial infarction 6 months or decompensated heart failure NYHA class III ; 61607; previous or concomitant use of any anti-cancer therapy other than the platinum-taxane 1st line chemotherapy; 61607; concomitant use of any other investigational agent; 61607; any prior investigational anti-cancer vaccine or monoclonal antibody; 61607; known allergy to murine proteins; 61607; any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures; 61607; clinically significant active infection; 61607; concomitant use of any immunosuppressive agent e.g., steroids, cyclosporin, etc. ; 61607; major surgery within the previous 2 weeks; 61607; radiotherapy within the previous 4 weeks; 61607; any significant toxicity from prior chemotherapy; 61607; unreliability or inability to follow protocol requirements. |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |