E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cancer : Malignant Ascites |
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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 demonstrate the superiority of a treatment with paracentesis plus removab over a treatment with paracentesis alone in terms of puncture free survival. |
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E.2.2 | Secondary objectives of the trial |
To assess quality of life, patient’s health state, determine efficacy, and safety as well as to collect objective data regarding timing for the first post-baseline therapeutic ascites puncture. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Signed and dated informed consent, 2.Histological confirmed diagnosis of cancer, 3.Patients with symptomatic malignant ascites requiring therapeutic ascites puncture. The ascites volume estimated by the radiologist must exceed 1 liter. 4.EpCAM positive tumor cells in the ascites fluid, 5.Age: >/= 18 years, 6.Karnofsky Index >/=60 7.Negative pregnancy test at screening in women with childbearing potential, 8.Life expectancy >8 weeks, 9.At least 1 therapeutic ascites puncture within 5 weeks before screening puncture. 10.Patients who are refractory/resistant to chemotherapy or where the standard chemotherapy is no longer feasible |
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E.4 | Principal exclusion criteria |
1.Acute or chronic infections, 2.Exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C), before first infusion 3.Previous treatment with mouse or rat monoclonal antibodies, 4.Known or suspected hypersensitivity to removab or similar antibodies, 5.Inadequate renal function (Creatinine >1.5 x upper limit of normal [ULN]), 6.Inadequate hepatic function (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase >/= 5 x ULN; bilirubin >1.5 x ULN), 7.Platelets <80000 cells/qmm; absolute neutrophil count (ANC) <1500 cells/qmm, 8.Body mass index <17, 9.Patients with a reduced nutritional status requiring predominantly parenteral nutrition (>50% of energy intake), 10.Patients with gastric or small bowel feeding tube at study entry, 11.Patients with ileus within the last 30 days, 12.Patients with any other severe disease that would render a participation in the study an undue risk, 13.Known brain metastases in cancer history, 14.Pregnant or nursing women or women with childbearing potential and males who are not using an effective contraceptive method during the study and at least 3 months after the last infusion, 15.History of myocardial infarction, 16.Signs or symptoms of relevant cardiovascular disease, congestive heart failure or cardiac arrhythmias (New York Heart Association [NYHA] class >II), 17.History of cerebrovascular accident, 18.Patients with portal vein obstruction or portal vein thrombosis diagnosed by CT-scan at screening, 19.Patients with extensive liver metastases (>70% of the liver is metastasized), 20.Inadequate respiratory function in the opinion of the investigator, 21.Any further condition which according to the investigator results in an undue risk of the patient by participating in the present study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Puncture free survival, defined as time after day 0/treatment period to first need for therapeutic ascites puncture or death, whichever occurs first. Additional measures will be performed to objectify the need for therapeutic ascites puncture (first part of the composite primary efficacy variable) ex post facto (see also additional variables). The therapeutic ascites puncture will be carried out if the ascites volume, as estimated by the radiologist from the CT, exceeds 1 liter and the patient has symptomatic ascites according to the ascites signs and symptoms assessment |
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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 | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 |
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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.8.5 | 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 | 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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |