BYL719 for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAnthony Nichols

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with resectable head and neck squamous cell carcinoma (HNSCC) who can undergo surgery, have a life expectancy over 6 months, and proper organ function. They must not be pregnant, agree to use contraception, and should not have had certain treatments or conditions that could affect the study drug's intake or efficacy.

Inclusion Criteria

My doctor has checked my medications and made necessary adjustments.

My cancer is a type of squamous cell carcinoma located in the head or neck.

I am 18 years old or older.

+10 more

Exclusion Criteria

Patient has history of hypersensitivity to any drugs or metabolites or similar chemical classes as BYL719

I am on medication that affects my heart's rhythm and cannot change it.

Patients with known positive serology for human immunodeficiency virus (HIV)

+15 more

Participant Groups

The trial is testing BYL719 in patients with HNSCC before they go for surgery. It aims to see how this drug affects cancer biomarkers. Participants will take BYL719 orally in a single-center study designed to prepare them for their upcoming surgical treatment.

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

14 days of BYL719 treatment, open label