Clinical Trial Page

Summary
EudraCT Number:2005-001700-39
Sponsor's Protocol Code Number:IP-REM-PK-01-EU
National Competent Authority:Germany - PEI
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2005-07-14
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - PEI
A.2EudraCT number2005-001700-39
A.3Full title of the trial
Determination of systemic exposure and characterization of pharmacokinetics of the tri-functional antibody catumaxomab (anti-EpCAM X anti-CD3) administered intraperitoneally in EpCAM positive cancer patients with malignant ascites
A.4.1Sponsor's protocol code numberIP-REM-PK-01-EU
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorFresenius Biotech GmbH
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product namecatumaxomab
D.3.4Pharmaceutical form Concentrate for solution for infusion
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntraperitoneal use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Yes
D.3.11.13.1Other medicinal product typeMonoclonal antibody developed by hybridoma method
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
epithelial cell adhesion molecule (EpCAM) expressing tumors in patients with malignant ascites requiring therapeutic ascites puncture
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 9.1
E.1.2Level LLT
E.1.2Classification code 10025538
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main 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
E.2.2Secondary 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
E.2.3Trial contains a sub-study No
E.3Principal 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
E.4Principal 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, gamma﷓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.
E.5 End points
E.5.1Primary 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
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other 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.8.4.1Number of sites anticipated in Member State concerned4
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial 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
The end of the trial is defined as last visit of the last patient
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years0
E.8.9.1In the Member State concerned months11
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years0
E.8.9.2In all countries concerned by the trial months11
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 10
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
After the end of the study no further treatment modalities are planned for the patients. They will be medicated according ot the general treatment standards for tumour patients.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2005-07-18
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-09-14
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2006-11-07

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