Squamous Cell Carcinoma of Head and NeckPhase 1NCT02537223

Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer

A Phase 1 study testing BYL719, Cisplatin and Intensity modulated radiation therapy (IMRT) in people with Squamous Cell Carcinoma of Head and Neck and Locoregionally Advanced, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma of Head and Neck, Locoregionally Advanced
What is being tested?: BYL719, Cisplatin and Intensity modulated radiation therapy (IMRT)
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteCanada
Study dates: Sep 2015to 20 Feb 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

Performance status of 0-1
Adequate organ function
Able to swallow and retain oral medication

Who cannot join

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

Show all 19Show fewer

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 moderate or strong inhibitors or inducers of isoenzymes CYP34A or CYP2C8
Have impaired gastrointestinal (GI) function or GI disease

Trial locations and contacts

1 site in 1 country.

Canada1 site

Princess Margaret Cancer Centre
Toronto, Ontario, M3G 2M9

Other trials in Canada

About this study

Official title: Phase I Trial of BYL719 in Combination With Concurrent Cisplatin-based Chemoradiotherapy in Patients With Locoregionally Advanced Squamous Cell Carcinoma of Head and Neck (LA-SCCHN)

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.

Read the detailed description

Participants will be screened for eligibility within 30 days of the intended start of the study treatment. Procedures for research purposes done during screening include archival tumor tissue collection for pharmacodynamic and predictive biomarker research and optional HPV status (if not already known).

Eligible participants will take BYL719, by mouth, once a day, starting one week prior to start of radiation and chemotherapy, for 8 weeks. The starting dose of BYL719 is 200 mg. Participants will be asked to record their doses on a study drug diary. Participants will also receive radiation therapy every day from Monday to Friday for 7 weeks.

Chemotherapy (cisplatin) will be given intravenously on Monday of weeks 1, 4, and 7 (48 hour window during weeks 4 and 7).

While receiving the study treatment, participants will have tests and procedures done once every week for safety purposes.

After the end of the study treatment, participants will be asked to visit the centre every 2 weeks up to week 8 for additional tests and procedures for safety purposes. Between week 8-12 after completing the study treatment, participants will have tumor measurements done to assess efficacy.

Participants will continued to be followed every 3 months up to 1 year, then every 6 months for 2 years (total of 3 years).

Conditions: Squamous Cell Carcinoma of Head and Neck, Locoregionally Advanced
Being tested: BYL719, Cisplatin, Intensity modulated radiation therapy (IMRT)
Medical subject headings: Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BYL719Drug
CisplatinDrug
Intensity modulated radiation therapy (IMRT)Radiation

Study groups in NCT02537223
Study group	Role	What they receive
BYL719, Cisplatin, and Radiation Therapy	Experimental	BYL719, orally, at a starting dose of 200-350 mg, once daily, for 7 weeks. Cisplatin, intravenously, at 100 mg/m2 over 1 hour, every 3 weeks for 3 doses. Radiation therapy, Monday to Friday, for 7 weeks. Receives: Drug: BYL719; Drug: Cisplatin; Radiation: Intensity modulated radiation therapy (IMRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Treatment Emergent Side Effects
Measured: 3 years

Secondary outcomes (6)

Time from date of enrollment to date of relapse disease
Measured: 3 years
Number of patients who do not have locoregional relapse of disease
Measured: 6 months
Number of patients who do not have locoregional relapse of disease
Measured: 12 months
Number of patients who do not have a distant metastatic relapse of disease
Measured: 6 months
Number of patients who do not have a distant metastatic relapse of disease
Measured: 12 months
Time from date of enrolment to date of death
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201520 Feb 2020

First posted1 Sep 2015 (estimated)
Study startSep 2015
Primary completion14 Jun 2018
Study completion20 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02537223
Sponsor's protocol ID: BCX-001
Status last verified: Apr 2021
First submitted: 28 Aug 2015
Last updated: 19 Apr 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)

All Squamous Cell Carcinoma of Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Trial of BYL719 in Combination With Concurrent Cisplatin-based Chemoradiotherapy in Patients With Locoregionally Advanced Squamous Cell Carcinoma of Head and Neck (LA-SCCHN)
ClinicalTrials.gov ID: NCT02537223
Acronym / sponsor ID: BCX-001
Conditions: Squamous Cell Carcinoma of Head and Neck, Locoregionally Advanced
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Collaborators: Novartis Pharmaceuticals
Study start: Sep 2015
Primary completion: 14 Jun 2018 (actual)
Study completion: 20 Feb 2020 (actual)
First posted: 1 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is the first time BYL719 will be combined with radiation and chemotherapy.

Detailed description

Chemotherapy (cisplatin) will be given intravenously on Monday of weeks 1, 4, and 7 (48 hour window during weeks 4 and 7).

While receiving the study treatment, participants will have tests and procedures done once every week for safety purposes.

Participants will continued to be followed every 3 months up to 1 year, then every 6 months for 2 years (total of 3 years).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BYL719, Cisplatin, and Radiation Therapy	Experimental	Drug: BYL719, Drug: Cisplatin, Radiation: Intensity modulated radiation therapy (IMRT)BYL719, orally, at a starting dose of 200-350 mg, once daily, for 7 weeks. Cisplatin, intravenously, at 100 mg/m2 over 1 hour, every 3 weeks for 3 doses. Radiation therapy, Monday to Friday, for 7 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BYL719	Drug	BYL719, Cisplatin, and Radiation Therapy
Cisplatin	Drug	BYL719, Cisplatin, and Radiation Therapy
Intensity modulated radiation therapy (IMRT)	Radiation	BYL719, Cisplatin, and Radiation Therapy

Primary outcome

Number of Treatment Emergent Side Effects
Time frame: 3 years

6 secondary outcomes

Time from date of enrollment to date of relapse disease
Time frame: 3 years
Number of patients who do not have locoregional relapse of disease
Time frame: 6 months
Number of patients who do not have locoregional relapse of disease
Time frame: 12 months
Number of patients who do not have a distant metastatic relapse of disease
Time frame: 6 months
Number of patients who do not have a distant metastatic relapse of disease
Time frame: 12 months
Time from date of enrolment to date of death
Time frame: 3 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.

Related trials for Squamous Cell Carcinoma of Head and Neck

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aaron Hansen, M.D. principal investigator

Princess Margaret Cancer Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment Emergent Side Effects (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02537223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.