E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sqamous Cell Carcinoma of the Head & Neck (SCCHN) |
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MedDRA Classification |
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 explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced SCCHN. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of this trial include the assessment of effects of lapatinib on tumour cell proliferation, evaluation of clinical activity and safety of lapatinib, correlation of early radiologial responses with biologic markers and the identification of potential genetic predictors that may enhance response to lapatinib in the patient population.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Willing and able to sign a written informed consent. 2.Histologically or cytologically confirmed diagnosis of SCCHN. 3.Stage III, IVA and IVB disease will be eligible, who are to receive chemoradiation therapy as primary treatment (total dose ≥ 66 Gy). Subjects with distant metastases (stage IVC) will be excluded. 4.Willing and able to have a tumour biopsy taken at screening and a second tumour biopsy taken during lapatinib/placebo administration. 5.Male or female 18 years of age. 6.ECOG performance status 0, 1 or 2.
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E.4 | Principal exclusion criteria |
1.Subjects with paranasal sinuses and nasal cavity tumours; 2.Subjects who have received prior systemic chemotherapy given with curative intent; 3.Subjects who received prior radiotherapy; 4.Prior or concurrent treatment with tyrosine kinase inhibitors; 5.Use of any investigational agent within 30 days or 5 half-lives, whichever is longer, preceding the first dose of lapatinib; 6.Concurrent use of CYP3A4 inducers or inhibitors; 7.Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; 8.Distant metastases, ie Stage IVC; 9.Subjects taking any prohibited medication
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E.5 End points |
E.5.1 | Primary end point(s) |
To estimate the percentage of apoptosis/necrosis in tumour biopsy samples of subjects with SCCHN following two weeks of lapatinib/placebo treatment. |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | 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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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As defined in Section 12 of the protocol, the end of the trial is 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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
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 | 2 |