Cancer : Malignant Ascites MedDRA version: 8.1 Level: LLT Classification code 10025538 Term: Malignant ascites
Conditions
Interventions
Product Name: INN: catumaxomab (removab)
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 (only Population A), 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 puncture within 5 weeks before screening puncture, 10.Patients who are refractory/resistant to chemotherapy or where the standard chemotherapy is no longer feasible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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), 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of a treatment with paracentesis plus removab over a treatment with paracentesis alone in terms of puncture free survival;Secondary Objective: 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. ;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) retrospectively by evaluating additional variables to objectify the need for therapeutic ascites puncture (see also additional variables to objectify the need for therapeutic ascites puncture). 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. | — |
Countries
Czech Republic, Estonia, Latvia, Lithuania, United Kingdom
Outcome results
None listed