NCT03138070

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 tumor biopsy will be evaluated for primary and secondary pharmacodynamic endpoints.

Conditions

• Head and Neck Squamous Cell Cancer

Interventions

Type	Name	Description
DRUG	BYL719	BYL719 400 mg daily by mouth continue for 14 days

Timeline

• Start date: 2017-10-20
• Primary completion: 2021-09-13
• Completion: 2025-11-26
• First posted: 2017-05-03
• Last updated: 2026-01-28

Locations

1 site across 1 country: Canada