Phase I Study of Olaparib With Cisplatin Based Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria: * Histologically confirmed high risk, locally advanced HNSCC patients (TNM staging: T-any N2/3 M0, bulky T3 or T4 N-any M0) who would normally be offered cisplatin-based radical chemoradiotherapy * Estimated life expectancy of at least 12 weeks * WHO performance status of 0 or 1 * Aged ≥18 years of age * Adequate major organ function * Willing to use contraception for the duration of the trial treatment and for six months after completion of treatment * Able to give informed consent * Willing and able to comply with the protocol for the duration of the study Exclusion Criteria: * Head \& neck cancers of the following types: * Nasopharyngeal and paranasal sinus tumours, * Oral squamous cell carcinomas (tumours of the oral cavity), * Human Papilloma Virus positive oropharyngeal tumours (tonsillar and tongue base tumours) * Confirmed distant metastatic disease * Previous chemotherapy or radiotherapy for the treatment of HNSCC tumour * Previous therapy with a PARP inhibitor * Pre-existing gastrointestinal disorders that may interfere with the delivery or absorption of olaparib * Grade 3 or 4 peripheral neuropathy * Significant hearing difficulties or tinnitus (deaf patients can be included) * The current use of drugs which are known to inhibit or induce CYP3A4