A Window of Opportunity Study to Assess the Modulation of Biomarkers in Head and Neck Squamous Cell Cancer (HNSCC) By Preoperative Treatment With BYL719

Official Title

A Window of Opportunity Study to Assess the Modulation of Biomarkers in Head and Neck Squamous Cell Cancer (HNSCC) By Preoperative Treatment With BYL719

Summary:

Single centre, single arm, preoperative window of opportunity study with a biomarker endpoint (expression profiling by RNA sequencing). Patients with resectable, histologically confirmed head and neck squamous cell carcinoma (HNSCC) for whom surgical treatment is planned as definitive management will be eligible.

Trial Description

Primary Outcome:

• Phospho-S6 (235/6) Expression

Secondary Outcome:

• Phospho-AKT Levels (Ser473)
• Ki-67 Levels
• Severity of Adverse Events

This is a single centre, single arm, preoperative window of opportunity study with a biomarker endpoint (expression profiling by RNA sequencing). Patients with resectable, histologically confirmed head and neck squamous cell carcinoma (HNSCC) for whom surgical treatment is planned as definitive management will be eligible. The median time from consultation to major head and neck surgery at our institution is 3.2 +/- 2.0 weeks (1 standard deviation). To provide the maximal opportunity to achieve a biomarker response and potentially observe clinical responses, patients will receive BYL719 orally daily at the maximum tolerated dose (400 mg/day) for 14 days. All patients will receive surgery as the standard of care. The gene expression profile, including Ki-67, from the surgical specimen and mandatory baseline tumour biopsy will be evaluated for primary and secondary pharmacodynamic endpoints.

View this trial on ClinicalTrials.gov