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BYL719 for Head and Neck Cancer

N/A

Waitlist Available

Led By Anthony Nichols

Research Sponsored by Lawson Health Research Institute

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and within 14 days of last dose

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and at surgery

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phospho-S6 (235/6) Expression

Secondary outcome measures

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

Swelling face

Arthralgia

Blood albumin decreased

Alpha hydroxybutyrate dehydrogenase increased

Vision blurred

Sinus tachycardia

Abdominal discomfort

Bilirubin conjugated increased

Hypochloraemia

Dyspnoea exertional

Abdominal distension

Abdominal pain

Dysphagia

Haemorrhoids

Chest discomfort

Non-cardiac chest pain

Paronychia

Blood creatine phosphokinase MB increased

Blood glucose increased

Blood lactate dehydrogenase increased

Back pain

Musculoskeletal stiffness

Insomnia

Dysphonia

Thrombocytopenia

Protein urine present

Neck pain

Palpitations

Speech disorder

Conjunctivitis

Abdominal pain lower

Agitation

Skin injury

Pain in extremity

Epistaxis

Gastrointestinal haemorrhage

Pulmonary tuberculosis

Pulmonary embolism

Deep vein thrombosis

Tachycardia

Cataract

Visual impairment

Gingival bleeding

Stomatitis

Pain

Erythrasma

Blood pressure increased

Haemoglobin increased

Alkalosis

Hypercholesterolaemia

Hyperglycaemia

Muscular weakness

Musculoskeletal pain

Myalgia

Hypoaesthesia

Depression

Dysphoria

Dysuria

Atelectasis

Oropharyngeal pain

Pharyngeal ulceration

Skin exfoliation

Bronchitis

Chills

Activated partial thromboplastin time prolonged

Somnolence

Skin fissures

Metastases to bone

Motion sickness

Eyelid oedema

Injection site swelling

Asthma

Pulmonary arterial hypertension

Tachypnoea

Abnormal faeces

Faeces hard

Weight decreased

Chronic sinusitis

Infusion related reaction

Urinary retention

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

MEK162 45 mg BID

BYL719 350 mg QD

INC280 400 mg BID Tab/600 mg BID Cap

LDK378 750 mg QD

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,413 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for participants in this trial?

"The clinical trial, which was last updated on June 14th, 2022 and originally posted on October 20th, 2017, is not currently looking for candidates. Although this specific study has completed recruitment, there are 700 other trials that patients can participate in."

Answered by AI

What is the projected number of participants for this clinical trial?

"This study is not currently looking for patients to enroll. According to the information found on clinicaltrials.gov, this trial was first posted on October 20th, 2017 and last updated on June 14th, 2022. There are many other studies that may be a better fit for you; 666 trials for head and neck squamous cell cancers and 34 for BYL719 are admitting patients right now."

Answered by AI

Recent research and studies

International Journal of CancerJournal

A Controlled Trial of HNSCC Patient‐derived Xenografts Reveals Broad Efficacy of Pi3kα Inhibition in Controlling Tumor Growth

Ruicci, Kara M., Jalna Meens, Ren X. Sun, Giananthony Rizzo, Nicole Pinto, John Yoo, Kevin Fung, et al.. 2018. “A Controlled Trial of HNSCC Patient‐derived Xenografts Reveals Broad Efficacy of Pi3kα Inhibition in Controlling Tumor Growth”. International Journal of Cancer. Wiley. doi:10.1002/ijc.32009.

clinicaltrials.govStudy

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

2017. "A Window of Opportunity Study to Assess the Modulation of Biomarkers in Head and Neck Squamous Cell Cancer (HNSCC) By Preoperative Treatment With BYL719". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03138070.

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