E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with malignant ascites due to epithelial 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 |
The primary objective of the study is to evaluate the safety of the 3 hour i.p. infusion of catumaxomab with and without prednisolone. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to determine the efficacy, additional safety, Quality of Life, and ascites-related symptom score of 3 hours i.p. infusion of catumaxomab with and without prednisolone. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be enrolled in this study only if they meet all of the following criteria: ·Signed and dated informed consent, ·Age: ³18 years, ·Karnofsky index ≥60%, ·Histological confirmed diagnosis of epithelial cancer), ·Patients with malignant ascites requiring therapeutic ascites puncture, ·Patients where no effective standard treatment is available or no longer feasible, ·Life expectancy >12 weeks, ·BMI between 17 and 40 kg/m2 |
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E.4 | Principal exclusion criteria |
Patients will not be enrolled in this study if they meet any of the following criteria: ·Documented acute or chronic infection, ·Concomitant treatment with other investigational product, cancer chemo-, or radiotherapy, ·Exposure to an investigational product within the last 28 days before the start of the first infusion and during the study, ·Previous treatment with murine monoclonal antibodies, ·Known or suspected hypersensitivity to catumaxomab or similar antibodies, ·Inadequate respiratory function, including pleural effusion, ·Inadequate renal function (creatinine >1.5 ` upper limit of normal [ULN], ·Inadequate hepatic function (aspartate aminotransferase (AST), alanine aminotransferase (ALT), ³ 2.5 ` ULN; bilirubin >1.5 ` ULN),· Platelets <80000 cells/mm3; absolute neutrophil count (ANC) <1500 cells/mm3, ·Hypoalbuminemia: lower than 3 g/dL ·Partial thromboplastin time (PTT) >2 x ULN (not worse than Common Toxicity criteria [CTC] grade 2) ·Hemoglobin <8g/dL, ·Patients requiring parenteral nutrition, ·Patients with ileus or subileus within the last 30 days, ·Signs or symptoms of relevant cardiovascular disease, congestive heart failure or cardiac arrhythmias (New York Heart Association [NYHA] class >II), ·Liver metastases with volume >70% of liver metastasized tissue, ·Known portal vein obstruction, ·Brain metastases, ·Pregnant (as evidenced by positive pregnancy test at screening), or nursing women or women of childbearing potential and men who are not using an effective contraceptive method during the study and at least 3 months after the last infusion, ·Unable or unwilling to comply fully with the protocol, ·Patients with any other severe disease that would render a participation in the study an undue risk according to judgment of investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Composite safety score of 3 hours i.p. infusion of catumaxomab with and without prednisolone. The composite safety score is calculated from the frequency and intensity of the main known adverse events (AEs) caused by catumaxomab: fever, nausea, vomiting, and abdominal pain. The CTC-grade of these AEs will be summarized using an AE-score. The composite safety score will be compared between the 2 treatment groups. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
catumaxomab con e senza prednisolone |
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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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
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 | 0 |