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Head and Neck Squamous Cell CancerPhase 1NCT02282371

Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)

A Phase 1 study testing Cetuximab, BYL719 and IMRT (Intensity-Modulated Radiation Therapy) in people with Head and Neck Squamous Cell Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

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 1b study, which means that the purpose of the study is to establish the maximum dose of a pill drug called BYL719, when given with a standard treatment for patients with head and neck squamous cell cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Cancer
What is being tested?
Cetuximab, BYL719 and IMRT (Intensity-Modulated Radiation Therapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
6 sitesUnited States
Study dates
30 Oct 2014to 22 Oct 2021
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

  • Locally and/or regionally advanced (M0) head and neck squamous cell carcinoma (AJCC Stage III-IVB), cytologically or pathologically confirmed by Department of Pathology at MSKCC, for which curative-intent radiation therapy is planned.
  • Age ≥ 18 years
  • ECOG Performance Status ≤ 1
  • Adequate organ function and laboratory parameters as defined by:
  • Absolute neutrophil count ≥ 1.0 x 109/L
  • Hemoglobin ≥ 9 g/dl
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  • Platelets ≥ 100 x 109/L
  • AST/SGOT and ALT/SGPT ≤ 2.5X ULN (upper limit of normal)
  • bilirubin ≤ 1.5X ULN
  • creatinine ≤ 1.5X ULN
  • Fasting glucose < 140 mg/dL
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for males at least 4 months thereafter and for females at least 3 months thereafter.
  • Negative serum pregnancy test (β-hCG) within 72 hours before starting study treatment for all women of childbearing potential.
  • Able to understand and voluntarily sign the informed consent form, and able to comply with the study visit schedule and other protocol requirements.
  • Low risk for tumor lysis syndrome (TLS)
  • Sexually active males must use a condom during intercourse while taking the drugs and for 16 weeks after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
  • Patient is able to swallow and retain oral medication

Who cannot join

  • Any prior known radiation therapy in head and neck area
  • Clinically significant cardiac disease or impaired cardiac function such as:
  • Congestive heart failure (CHF) requiring treatment (New York Heart Association ≥ grade 2), Left Ventricular Ejection Fraction (LVEF) ≤ 50% dose determined by multi-gated acquisition (MUGA) scan or echocardiogram, or uncontrolled arterial hypertension defined by blood pressure greater than 140/80 mmHg at rest (average of 3 consecutive readings)
  • History or current evidence of clinically significant cardiac arrhythmias, atrial fibrillation and/or conduction abnormality, (e.g. congenital long QT syndrome, high grade\complete AV blockage).
  • Acute coronary syndrome (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), for coronary angiography angioplasty and stenting), < 3 months prior to screening
  • QT interval adjusted according to Fredericia (QTcF) > 480 msec on screening EKG
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  • Patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
  • Patient with history of another malignancy within 2 years prior to starting study treatment, except for cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix
  • Patient who has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
  • Patient who has had systemic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
  • Patient who has undergone major surgery ≤ 4 weeks prior to starting study treatment or who has not recovered from side effects of such procedure
  • Any other condition that would, in the investigator's judgment. preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social/psychological complications
  • Impaired GI function or GI disease that may significantly alter the absorption of oral BYL719 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Patient who has participated in a prior therapeutic investigational drug study within 30 days prior to enrollment
  • Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
  • Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment. Switching to a different medication prior to the start of treatment is allowed; (Refer to Appendix 2).
  • Known positive serology for human immunodeficiency virus (HIV), active hepatitis B, and/or active hepatitis C infection
  • Patient has a known hypersensitivity to any of the excipients of BYL719
  • Patient has a known hypersensitivity to cetuximab or any other monoclonal antibody
  • Patient has a known history of non-compliance to medical regimen or inability to grant consent
  • Pregnant nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
  • Women Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment:
  • Sexually active males should use a condom during intercourse while taking drug and for 16 weeks after the final dose of study treatment and should not father a child in this period, but may be recommended to seek advice on conservation of sperm. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid b. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and through at least 16 weeks after the final dose of study treatment. Highly effective contraception is defined as either: i. Total abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception].
  • Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment iii. Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female study subjects, the vasectomized male partner should be the sole partner for that patient] iv. Use a combination of the following (both a+b):
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
  • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
  • Note: Hormonal contraception methods (e.g. oral, injected, and implanted) are not allowed as BYL719 may decrease the effectiveness of hormonal contraceptives.
  • Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
  • Patients with nasopharyngeal carcinoma are not eligible.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memorial Sloan Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey, 07939

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York

Other trials in United States

About this study

Official title: A Phase Ib Study of Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)

This is a phase 1b study, which means that the purpose of the study is to establish the maximum dose of a pill drug called BYL719, when given with a standard treatment for patients with head and neck squamous cell cancer.

Being tested
Cetuximab, BYL719, IMRT (Intensity-Modulated Radiation Therapy)
Keywords
Cetuximab, BYL719, IMRT (Intensity-Modulated Radiation Therapy), 14-116

What participants receive

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

  • CetuximabDrug

  • BYL719Drug

  • IMRT (Intensity-Modulated Radiation Therapy)Radiation

Study groups in NCT02282371
Study groupRoleWhat they receive
Cetuximab + BYL719 + IMRTExperimentalCetuximab loading dose, 400 mg/m2 intravenously (IV). IMRT, 1 fraction/day, up to total of approximately 70 Gy, over approximately 33 treatment days Cetuximab 250 mg/m2 weekly IV X 7 weeks Daily BYL719, according to dose escalation scheme followup clinic visits every 3 months for 2 years,every 6 months for the next 3 years, and annually thereafter.
Receives: Drug: Cetuximab; Drug: BYL719; Radiation: IMRT (Intensity-Modulated Radiation Therapy)

What is being measured

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

  1. determine the phase II-recommended dose of BYL719

    Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable.

    Measured: 2 years

Secondary outcomes (1)

  1. Adverse events

    Adverse events (AEs) will be assessed according to NCI common toxicity criteria (CTC) version 4. DLT is defined as any toxicity requiring radiotherapy treatment delay of ≥ 7 calendar days, or any ≥ Grade 3 toxicity (other than those excluded from the DLT definition, below). Patients who require dose reduction in BYL719 due to toxicity will be deemed to have experienced DLT.

    Measured: 2 years

Timeline

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

  1. First posted4 Nov 2014 (estimated)
  2. Study start30 Oct 2014
  3. Primary completion22 Oct 2021
  4. Study completion22 Oct 2021

Resources

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
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02282371
Sponsor's protocol ID
14-116
Status last verified
Oct 2021
First submitted
30 Oct 2014
Last updated
26 Oct 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cetuximab, BYL719 and IMRT (Intensity-Modulated Radiation Therapy) in people with Head and Neck Squamous Cell Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

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 17 inclusion and 29 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

determine the phase II-recommended dose of BYL719 (time frame: 2 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 NCT02282371.

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 26 Oct 2021.

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