E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
epithelial cell adhesion molecule (EpCAM) expressing tumors in patients with malignant ascites requiring therapeutic ascites puncture |
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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 | 10025538 |
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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 |
- Determination of systemic exposure of catumaxomab during and after four intraperitoneal infusions with increasing doses - Characterization of pharmacokinetics of catumaxomab after the second, the third and the fourth intraperitoneal infusion |
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E.2.2 | Secondary objectives of the trial |
- Characterization of cytokine levels after intraperitoneal administration of catumaxomab· Assessment of safety and tolerability of catumaxomab - Evaluation of efficacy of catumaxomab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed and dated informed consent, 2. Histologically confirmed diagnosis of cancer, 3. Malignant ascites requiring peritoneal puncture, 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. 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 catumaxomab or similar antibodies, 5. Inadequate renal function (creatinine >1.5 ´ upper limit of normal [ULN]), 6. Inadequate hepatic function (aspartate aminotransferase, alanine aminotransferase, gammaï·“glutamyltransferase ³5 ´ ULN; bilirubin >1.5 ´ ULN), 7. Platelets <80000 cells/mm3; absolute neutrophil count (ANC) <1500 cells/mm3, 8. Body mass index <17, 9. Condition of veins which do not allow frequent blood sampling, 10. Patients with a reduced nutritional status requiring predominantly parenteral nutrition (>50% of energy intake), 11. Patients with gastric or small bowel feeding tube at study entry, 12. Patients with ileus within the last 30 days, 13. Known brain metastases in cancer history, 14. Patients with any other severe disease that would render a participation in the study an undue risk, 15. History of myocardial infarction, 16. Signs or symptoms of relevant cardiovascular disease, congestive heart failure or relevant cardiac arrhythmia (New York Heart Association [NYHA] class >II, for definition see Attachment 4), 17. History of cerebrovascular accident 18. 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, 19. Patients with portal vein obstruction or portal vein thrombosis diagnosed by CT-scan at screening, 20. Patients with extensive liver metastases (>70% of the liver is metastasized), 21. Inadequate respiratory function in the opinion of the investigator, 22. Supposition that patient is not able or willing to comply with the requirements of the study, 23. 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) |
- Determination of systemic exposure of catumaxomab during and after four intraperitoneal infusions with increasing doses - Characterization of pharmacokinetics of catumaxomab after the second, the third and the fourth intraperitoneal infusion |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | No |
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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The end of the trial is defined as 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 | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |