E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced gastric adenocarcinoma and intended curative gastrectomy (R0 resection). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10017812 |
E.1.2 | Term | Gastric neoplasms malignant |
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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 |
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility. |
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E.2.2 | Secondary objectives of the trial |
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information secondary on relevant efficacy parameters. |
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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. Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3) 3. Intended curative gastrectomy (en-bloc-R0-resection considering the standardized D2-schedule) 4. Serosal infiltration (T3/T4, N+/-, M0) or T2b, N+/-, M0 confirmed by immediate section with histopathologic assessment during surgery 5. Male or female at an age of 18 years or older 6. Karnofsky index >/= 70 7. Negative pregnancy blood test at screening in women with childbearing potential |
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E.4 | Principal exclusion criteria |
1. Presence of distant metastases 2. Macroscopic and microscopic*) residual tumor present after surgery 3. Pancreas resection (also partial) or thoracotomy 4. Exposure to prior cancer therapy (surgery, chemo- or radio-therapy) or planned adjuvant chemo- or radiotherapy of the current gastric cancer 5. Previous treatment with non-humanized mouse or rat monoclonal antibodies 6. Known/suspected hypersensitivity to catumaxomab or similar antibodies 7. Any cancer disease or any cancer treatments within the last 5 years 8. Presence of constant immunosuppressive therapy within the last 28 days prior to the first administration of catumaxomab 9. Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension 10. Presence of symptomatic heart failure or occlusive arterial diseases 11. Inadequate renal function (Creatinine >1.5 x ULN), 12. Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin ≥ 1.5 x ULN) 13. Platelets <75000 cells/mm3; absolute neutrophil count <1500 cells/mm3 14. Patient had a bowel obstruction within the last 30 days 15. Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least three months after the last infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms) 16. Presence of any acute or chronic systemic infection 17. Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study 18. Patient is an employee of any involved study investigator or any involved institution including the study sponsor 19. Parallel participation in another clinical trial or previous participation in this study 20. Treatment with another investigational product during this study or during the last 30 days prior to study start *): according to the results of the immediate section during surgery |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Frequency, relationship and seriousness of adverse events (AEs) - Clinically relevant laboratory results (hematology with differential count, clinical chemistry, coagulation tests, DABA and urinalysis), - Vital functions (SBP/DBP, HR, T°) - Electrocardiogram (ECG) - Physical examination - Number and duration of hospitalizations - Peri- and postoperative outcome |
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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) | 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 | 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 |
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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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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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Last subject last study phone contact |
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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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |