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BYL719 for Head and Neck Cancer

N/A
Waitlist Available
Led By Anthony Nichols
Research Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed squamous cell carcinoma of the head and neck
Age ≥18 years
Must not have
Patient receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment
Patients with known distant metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and at surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat head and neck cancer using RNA sequencing.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of BYL719 are not listed here, common ones may include digestive issues, fatigue, blood disorders, potential allergic reactions similar to other drugs in its class, and possibly changes in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of squamous cell carcinoma located in the head or neck.
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I am 18 years old or older.
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My organs and bone marrow are working well.
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I am eligible for surgery aimed at curing my condition.
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I can swallow and keep down oral medication.
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I can take care of myself but might not be able to do heavy physical work.
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I will use a condom during sex while on the study drug and for 4 weeks after.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on medication that affects my heart's rhythm and cannot change it.
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My cancer has spread to distant parts of my body.
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I have diabetes that requires insulin or diabetes caused by steroids.
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I have a stomach or intestine problem that affects how I absorb pills.
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I am not taking drugs that strongly affect certain liver enzymes.
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I am currently taking warfarin or similar blood thinners.
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I have not received any live vaccines within a week before starting the study medication.
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I have a known heart condition.
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I still experience severe side effects from previous cancer treatments.
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I haven't had major surgery in the last 2 weeks or still recovering from one.
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I am not using highly effective birth control while on BYL719 treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline and at surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and at surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phospho-S6 (235/6) Expression
Secondary study objectives
Ki-67 Levels
Phospho-AKT Levels (Ser473)
Severity of Adverse Events

Side effects data

From 2019 Phase 2 trial • 66 Patients • NCT02276027
82%
Anaemia
73%
Aspartate aminotransferase increased
73%
Blood creatine phosphokinase increased
73%
Rash
64%
Diarrhoea
59%
Hypoalbuminaemia
50%
Oedema peripheral
45%
Hyponatraemia
45%
Pyrexia
41%
Vomiting
36%
Decreased appetite
36%
Hypocalcaemia
36%
Mouth ulceration
32%
Constipation
32%
Asthenia
32%
Dyspnoea
27%
Amylase increased
27%
Alanine aminotransferase increased
27%
Blood alkaline phosphatase increased
27%
Nausea
27%
Electrocardiogram QT prolonged
23%
Face oedema
23%
Hypokalaemia
23%
Dry mouth
18%
Gamma-glutamyltransferase increased
18%
Dizziness
18%
Hypertension
18%
Pruritus
18%
Hyperuricaemia
18%
Cough
18%
Pneumonia
14%
Blood bilirubin increased
14%
Troponin I increased
14%
Aphthous ulcer
14%
Fatigue
14%
Blood uric acid increased
14%
Haemoptysis
14%
Productive cough
14%
Abdominal pain upper
14%
Lipase increased
14%
Pleural effusion
14%
Protein total decreased
14%
Hypoproteinaemia
14%
Hypophosphataemia
9%
Sinus tachycardia
9%
Vision blurred
9%
Abdominal discomfort
9%
Swelling face
9%
Alpha hydroxybutyrate dehydrogenase increased
9%
Bilirubin conjugated increased
9%
Blood albumin decreased
9%
Hypochloraemia
9%
Arthralgia
9%
Dyspnoea exertional
9%
Abdominal distension
9%
Abdominal pain
9%
Dysphagia
9%
Haemorrhoids
9%
Chest discomfort
9%
Non-cardiac chest pain
9%
Paronychia
9%
Blood creatine phosphokinase MB increased
9%
Blood glucose increased
9%
Blood lactate dehydrogenase increased
9%
Back pain
9%
Musculoskeletal stiffness
9%
Insomnia
9%
Dysphonia
9%
Thrombocytopenia
9%
Protein urine present
9%
Neck pain
5%
Gastrointestinal haemorrhage
5%
Palpitations
5%
Abdominal pain lower
5%
Conjunctivitis
5%
Skin injury
5%
Pain in extremity
5%
Speech disorder
5%
Agitation
5%
Epistaxis
5%
Pulmonary tuberculosis
5%
Pulmonary embolism
5%
Deep vein thrombosis
5%
Tachycardia
5%
Cataract
5%
Visual impairment
5%
Gingival bleeding
5%
Stomatitis
5%
Pain
5%
Erythrasma
5%
Blood pressure increased
5%
Haemoglobin increased
5%
Alkalosis
5%
Hypercholesterolaemia
5%
Hyperglycaemia
5%
Muscular weakness
5%
Musculoskeletal pain
5%
Myalgia
5%
Hypoaesthesia
5%
Depression
5%
Dysphoria
5%
Dysuria
5%
Atelectasis
5%
Oropharyngeal pain
5%
Pharyngeal ulceration
5%
Skin exfoliation
5%
Bronchitis
5%
Chills
5%
Activated partial thromboplastin time prolonged
5%
Somnolence
5%
Skin fissures
5%
Metastases to bone
5%
Motion sickness
5%
Eyelid oedema
5%
Injection site swelling
5%
Asthma
5%
Pulmonary arterial hypertension
5%
Tachypnoea
5%
Abnormal faeces
5%
Faeces hard
5%
Weight decreased
5%
Chronic sinusitis
5%
Infusion related reaction
5%
Urinary retention
5%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEK162 45 mg BID
BYL719 350 mg QD
INC280 400 mg BID Tab/600 mg BID Cap
LDK378 750 mg QD

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
14 days of BYL719 treatment, open label
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BYL719
2013
Completed Phase 2
~1230

Find a Location

Who is running the clinical trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
587 Previous Clinical Trials
402,380 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
431,405 Total Patients Enrolled
Anthony NicholsPrincipal InvestigatorLondon Health Sciences Centre

Media Library

BYL719 Clinical Trial Eligibility Overview. Trial Name: NCT03138070 — N/A
Head and Neck Cancers Research Study Groups: Arm 1
Head and Neck Cancers Clinical Trial 2023: BYL719 Highlights & Side Effects. Trial Name: NCT03138070 — N/A
BYL719 2023 Treatment Timeline for Medical Study. Trial Name: NCT03138070 — N/A
~2 spots leftby Dec 2025
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