BYL719 for Head and Neck Cancer

Overseen By Eric Winquist

Age: 18+

Sex: Any

Trial Phase: Academic

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

15 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, such as those that affect specific liver enzymes (CYP34A or CYP2C8), medications that prolong the QT interval, and warfarin. You must discontinue these at least 1 week before starting the study treatment, but switching to a different medication is allowed.

Research Team

Anthony Nichols

Principal Investigator

London Health Sciences Centre

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.

Life expectancy of greater than 6 months

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BYL719 orally daily at the maximum tolerated dose (400 mg/day) for 14 days

2 weeks

Daily oral administration

Surgery

All patients will receive surgery as the standard of care

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• BYL719

Trial Overview 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.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

14 days of BYL719 treatment, open label

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+