E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Curable Squamous cell carcinoma of the head and neck (SCCHN) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060121 |
E.1.2 | Term | Squamous cell carcinoma of head and neck |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine key pharmacokinetic parameters for zalutumumab as monotherapy in patients with SCCHN. |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety and secondary pharmacokinetic parameters of weekly administrations of i.v zalutumumab as monotherapy in patients with SCCHN. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males and females ≥ 18 years. 2. Histologically or cytologically confirmed diagnosis squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy. 3. Patient having based on the investigators judgment had disease progression and who are eligible for palliative treatment only. 4. Expected survival > 3 months. The patients must have performance status ≤ 2 according to WHO 5. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
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E.4 | Principal exclusion criteria |
1. Patients previously treated with any EGFR targeted therapy such as anti-EGFR monoclonal antibodies or small molecule inhibitors within 6 months prior to visit 2. 2. Received the following treatments within 4 weeks prior to Visit 2: • Cytotoxic or cytostatic anti-cancer chemotherapy • Total tumor resection • Radiotherapy of > 50 Gy to gross tumor volume 3. Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis 4. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities 5. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease 6. History of significant cerebrovascular disease 7. Known HIV infection 8. Known hepatitis B and/or hepatitis C 9. Screening laboratory values • Neutrophils < 1.5 x109/l • Platelets < 75 x109/l • ALAT > 2.5 times the upper limit of normal (unless known liver metastases) • ALP > 2.5 times the upper limit of normal (unless known bone metastases) • Bilirubin > 1.5 times the upper limit of normal • Creatinine clearance < 50 ml/min (measured or calculated by the Cockgroft-Gault method) 10. Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening) 11. Current participation in any other interventional clinical study 12. Patients with a BMI ≥ 30 kg/m2 13. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder) 14. Breast feeding women or women with a positive pregnancy test at Visit 1 15. Women of childbearing potential not willing to use adequate contraception as hormonal birth control or intrauterine device during study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary pharmacokinetic endpoints: The exposure (AUC) and peak concentration (Cmax) after single dose (1st infusion) and after multiple doses (4th infusion) of zalutumumab.
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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 | 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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |