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 | 8.1 |
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 investigate if HuMax-EGFr in combination with Best Supportive Care (BSC) is superior to BSC in terms of overall survival in non-curable patients with recurrent and/or metastatic disease who have failed at least one course of standard platinum-based chemotherapy |
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E.2.2 | Secondary objectives of the trial |
To compare HuMax-EGFr in combination with BSC to BSC with respect to efficacy, safety and Quality of Life (QoL) and to determine the pharmacokinetic profile of HuMax-EGFr |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
2) Progressive disease according to RECIST confirmed by an IRC during or within 6 months after failure or intolerance to standard platinum-based chemotherapy
3) Measurable disease according to RECIST confirmed by IRC
4) WHO PS ≤2
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E.4 | Principal exclusion criteria |
1) Three or more prior chemotherapy regimens other than platinum based chemotherapy.
2) Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3) Received the following treatments within 4 weeks prior to Visit 2: - Cytotoxic or cytostatic anti-cancer chemotherapy - Total tumor resection
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall Survival (OS) defined as the time from randomization until date of death from any cause. |
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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 | 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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
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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An interim statistical analysis will be performed when 116 deaths have been observed with a possibility of early stopping. If the hazard ratios required to show significance are not met when the interim analysis is performed, the trial will end when 236 deaths have been observed. The maximum number of patients to be recruited is 273.
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |