Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous … (NCT02537223) | Clinical Trial Compass
CompletedPhase 1
Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer
Canada9 participantsStarted 2015-09
Plain-language summary
This is a phase 1 study (the first step in testing a new drug or combination, to see how safe the drug and/or combination are) of investigational agent BYL719 in patients with locally advanced head and neck cancer (LA-SCCHN) in combination with standard radiation and chemotherapy (cisplatin).
BYL719 is a new drug that is able to bind (attach to) and block a protein called PI3K-alpha. PI3K-alpha is part of an important pathway called EGFR/PI3K/Akt. A pathway is a series of chemical reactions among proteins in the cells that are involved in the support of normal cellular function. If the pathway is too active, due to changes in those proteins, the pathway can lead to tumor cell growth, survival and invasion. BYL719 has been shown to stop cancers in laboratory and animal studies.
This study is the first time BYL719 will be combined with radiation and chemotherapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to comply with study requirements
* Age \>= 18 years
* Life expectancy \>6 months
* Previously untreated locally advanced squamous cell carcinoma of the head and neck eligible for cisplatin-based chemoradiation
* Not have received prior anti-neoplastic treatment within 2 years
* Resolved toxicities to Grade 1 or less
* Performance status of 0-1
* Adequate organ function
* Able to swallow and retain oral medication
Exclusion Criteria:
* Enrolled on another intervention clinical trial or in prior study within 30 days.
* Taking drugs with risk of prolonging the QT interval or of causing Torsades de Pointes
* Any condition that could increase the risk to the patient by participating which may include:
* Lung disease or uncontrolled hypertension
* Cardiovascular/vascular/cardiac disease
* Uncontrolled severe infection
* Impaired lung function
* Chronic treatment with corticosteroids/immunosuppressive agents
* Not recovered from previous toxicities
* Systemic therapy within 4 weeks of the start of the study treatment
* Active bacterial, fungal or viral infection
* Significant bleeding disorders
* Uncontrolled medical disorder or active infection
* Dementia or significantly altered mental status
* Diabetes mellitus requiring insulin treatment
* Another malignancy within 2 years of the start of the study treatment
* Received live attenuated vaccines within 1 week of the start of the study treatment
* Receiving treatment with drugs known to be…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.