E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unresected, locally advanced squamous cell carcinoma of the head and neck |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10024530 |
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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 eastimate, with pre-specified precision, the difference in local, regional control (LRC) rate at two years in subjects reciving Panitumumab plus chemioradiation (PCRT) or carcinoma of the head and neck (SCCHN) |
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E.2.2 | Secondary objectives of the trial |
To estimate the difference between 2 treatment regimens (PCRT vs CRT) on other measures of clinical benefit, including LRC, overall response rate (ORR), progression-free survival (PFS), overall survival (OS); and safety. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Histologically or cytologically confirmed SCC of oral cavity, oropharynx, hypopharynx, or larynx Stage III or Stage IVa-b disease (M0) according to the American Joint Committee on Cancer (AJCC) staging manual 6th edition ECOG performance status of 0 or 1 Bidimensionally measurable disease ≥ 10mm in at least 1 dimension Man or woman ≥ 18 years of age Hematological function, as follows ( ≤ 10 days prior to randomization): o Absolute neutrophil count (ANC) ≥ 1.5 x 109/L o Platelet count ≥ 100 x 109/L o Hemoglobin ≥ 9 g/dL Renal function, as follows ( ≤10 days prior to randomization): o Creatinine clearance ≥ 50 mL/min as calculated from a 24 hour urine collection (required for subjects with serum creatinine > ULN) or calculated by the Cockcroft-Gault method (refer to Section 4.1.3): Hepatic function, as follows (≤10 days prior to randomization): o Aspartate aminotransferase (AST) ≤ 2 x ULN o Alanine aminotransferase (ALT) ≤ 2 x ULN o Total bilirubin ≤ 2 X ULN Metabolic function, as follows (≤ 10 days prior to randomization): o Serum magnesium ≥ LLN Each subject must give written informed consent before participating in the any study specific procedure, enrollment or receiving any study medication Negative pregnancy test ≤ 72 hours prior to randomization (females of child bearing potential) |
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E.4 | Principal exclusion criteria |
Primary tumor of the nasopharynx, sinuses, salivary gland, or skin Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for ≥ 3 years Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule tyrosine kinase inhibitors of EGFr (eg, gefitinib, erlotinib, lapatinib) Prior surgery for SCCHN (except nodal sampling or biopsy for study disease) Prior radiotherapy in the planned field Prior systemic chemotherapy for the study cancer Major surgery ≤ 28 days before randomization or minor surgery ≤ 14 days before randomization with the exception that feeding tube placement, dental extractions, central venous catheter placement, and biopsies (endoscopic or otherwise), and nodal sampling are allowed at any time prior to randomization Subjects requiring prophylactic tracheostomy Known allergy or hypersensitivity to any component of the study drugs Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year prior to randomization Chronic obstructive pulmonary disease resulting in hospitalization due to pneumonia or respiratory decompensation ≤ 6 months prior to screening History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days prior to randomization. Any uncontrolled condition, which, in the opinion of the investigator, would interfere in the safe and timely delivery of study treatment Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, chronic active hepatitis B infection or any co-morbid disease that would increase risk of toxicity Pregnant or breast-feeding women Men not willing to use adequate contraception precautions for the duration of the study and for 1 month following the last administration of study treatment Women of childbearing potential not using adequate contraception precautions for the duration of the study and for 6 months following the last administration of study treatment Subject unwilling or unable to comply with study requirements Participation in other investigational device or drug studies ≤ 30 days before randomization Previously randomized into this study Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: Local Regional Control rate at 2 years |
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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 | 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 | No |
E.6.13 | Others | Information not present in EudraCT |
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 |
con chemioterapia standard chemio- radio |
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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.8.5 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |