A Phase I/II Study of Olaparib in Addition to Cisplatin Based Concurrent Chemoradiotherapy for Patients With High Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
This is a dose escalating Phase I/II trial evaluating the safety and tolerability of the
addition of olaparib to CRT in high risk locally advanced human papillomavirus (HPV)
negative Squamous Cell Carcinoma of the Head and Neck (HNSCC). A fixed dose of weekly
cisplatin and intensity-modulated radiation therapy (IMRT) will be used, with doses of
olaparib escalating for consecutive days and both dose level and duration will be increased
through each cohort.
This Phase I trial will assess how olaparib, a poly ADP ribose polymerase (PARP) inhibitor
is tolerated when added to standard chemoradiotherapy treatment.
Patients will be recruited from sites in the UK only.
A placebo controlled, randomised Phase II trial will follow once the recommended dose and
schedule of olaparib has been established.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of dose limiting toxicities
6 weeks post completion of treatment
Martin D Forster, MBBS
University College London, UK
United Kingdom: Medicines and Healthcare Products Regulatory Agency