E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epithelial Ovarian Cancer
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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 | 10033162 |
E.1.2 | Term | Ovarian epithelial cancer stage II |
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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 | 10033163 |
E.1.2 | Term | Ovarian epithelial cancer stage III |
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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 | 10033164 |
E.1.2 | Term | Ovarian epithelial cancer stage IV |
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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 | 10033161 |
E.1.2 | Term | Ovarian epithelial cancer stage I |
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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 the safety of an adjuvant treatment with catumaxomab in patients with epithelial ovarian cancer in terms of post-operative complication rate. |
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E.2.2 | Secondary objectives of the trial |
Determination of further safety data within the study period as well as efficacy data collected during post study follow-up. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed and dated informed consent form before any protocol-specific screening procedures 2. Patient has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) – IV) (histologically confirmed) 3. Karnofsky index > = 70 4. Female at an age of 18 years or older 5. Negative pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility)
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E.4 | Principal exclusion criteria |
1. Exposure to prior cancer therapy (surgery, investigational product-, chemo- or radio-therapy) specific for ovarian cancer 2. Previous treatment with non-humanized mouse or rat monoclonal antibodies 3. Known/suspected hypersensitivity to catumaxomab or similar antibodies 4. Second malignancy within the last 5 years (if directly influencing patient's overall prognosis) 5. Presence of constant immunosuppressive therapy 6. Presence of symptomatic heart failure or occlusive arterial diseases 7. Inadequate renal function (creatinine >1.5 x ULN) 8. Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin ≥ 1.5 x ULN) 9. Platelets <100.000 cells/mm3; absolute neutrophil count <1500 cells/mm3 10. Presence of any acute or chronic systemic infection 11. Presence of complete bowel obstruction 12. Presence of symptomatic brain metastases 13. Inadequate respiratory function in the opinion of the investigator 14. Any further condition which, according to the opinion of the investigator, results in an undue risk of the patient by participating in the present study 15. Parallel participation in another clinical trial or previous participation in this study 16. Pregnant or nursing women, or women with childbearing potential who are not using an effective contraceptive method during the study and for at least 3 months after the last infusion
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least one dose of catumaxomab. The events below will be regarded as specific postoperative complications:
• Surgical untoward event o Any fistula o Ileus requiring any surgical therapy o Bowel perforation o Anastomosis insufficiency requiring surgery o Wound infection o Hemorrhage requiring any therapy o Septicemia
• Non-surgical untoward event o Thromboembolism verified by at least one of the following objective diagnostic measures: - Positive V/Q scan (“high probability” according to PIOPED-criteria) - Angiography - CT-scan o Infection ≥ CTC Grade 3 o Pleural effusion requiring puncture o Renal insufficiency ≥ CTC Grade 3 o Liver failure ≥ CTC Grade 3 o Heart rhythm disorder requiring intervention o Neurological disorder ≥ CTC Grade 3 o Pulmonary edema
• Death, as an outcome of an event with fatal result
With regard to postoperative complications a study specific DSMB will evaluate all patients in a timely manner, as there is a significant frequency of complications due to the surgical procedure alone. The DSMB will be organised by sponsor's Drug Safety and Pharmacovigilance Department, similar to the general catumaxomab DSMB using the same procedures and workflows.
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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 | 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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 | 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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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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |