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Squamous Cell Carcinoma of the Head and NeckEarly Phase 1NCT03179956

Impact of Ribociclib on Head and Neck Squamous Cell Cancer

A Early Phase 1 study testing Ribociclib in people with Squamous Cell Carcinoma of the Head and Neck, run by Fox Chase Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A window of opportunity study which would allow brief treatment of HPV negative SCCHN with a CDK4/6 inhibitor, in the pre-operative setting, with biomarker analyses of pre and post treatment tissue. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ribociclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
2 Apr 2018to 10 Jan 2019
Phase
Early 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

  • Patient has an oral cavity cancer, HPV negative oropharynx cancer, or larynx cancer that is amenable to surgical resection for curative intent.
  • Surgical resection must be the part of their standard treatment for management of SCCHN cancer.
  • Patient must have archival tissue and must consent to provide pre-treatment archival tissue.
  • Patient has signed the Informed Consent (ICF) prior to any screening procedures and is able to comply with protocol requirements.
  • Male or Female patients who are 18 years or older.
  • Patients with known central nervous system (CNS) involvement must have clinically stable CNS tumor at the time of screening and should not be receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
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  • Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:
  • Absolute neutrophil count ≥1.5 × 109/L
  • Platelets ≥100 × 109/L
  • Hemoglobin ≥9.0 g/dL
  • Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication per protocol guidelines
  • INR ≤1.5
  • Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min
  • In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN. If the patient has liver metastases, ALT and AST <5 x ULN
  • Total bilirubin < ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome.
  • Standard, triplicate 12-lead ECG with the following parameters (defined as the mean of the triplicate ECGs):
  • QTcF interval at screening <450msec (using Fridericia's correction)
  • Resting heart rate 50-90 bpm
  • Women of child bearing potential must agree to use adequate means to prevent pregnancy
  • Men should either be sterile or must agree not to impregnate a women

Who cannot join

  • Patients with known hypersensitivity to ribociclib or similar class of agent.
  • Patients with concurrent malignancy which requires active treatment or malignancy within 3 years prior to starting study drug with the exception of basal or squamous cell carcinoma, or non-melanomatous skin cancer.
  • Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Patients with known history of HIV infection (testing not mandatory).
  • Patients with any other concurrent severe and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
  • Clinically significant, uncontrolled heart disease and/or recent events including any of the following:
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  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to screening
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Documented cardiomyopathy
  • Patients with Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening
  • History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality, high grade AV block (e.g. bifascicular block, Mobitz type II and third degree AV block) within 12 months of screening
  • Congenital long QT syndrome or family history of long QT syndrome
  • Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
  • Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication
  • Inability to determine the QT interval on screening (QTcF, using Fridericia's correction)
  • Systolic blood pressure (SBP) >160 mmHg or <90 mmHg at screening
  • Bradycardia (heart rate <50 at rest), by ECG or pulse, at screening
  • Patients receiving any of the following medications that cannot be discontinued 7 days prior to starting study drug (see Appendix II, Table 1 for details):
  • Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges
  • That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
  • That have a known risk to prolong the QT interval or induce Torsades de Pointes, herbal preparations/medications, dietary supplements.
  • Patients receiving or have received systemic corticosteroids ≤ 2 weeks prior to starting study drug or who have not fully recovered from side effects of such treatment. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
  • Patients receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
  • Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom ≥25% of the bone marrow (Ellis, 1961) was irradiated.
  • Patient who has had prior treatment for current oral cavity malignancy, except for biopsy for diagnostic purposes.
  • Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).
  • Patient has not recovered from all toxicities due to prior anticancer therapies for a different malignancy to NCI-CTCAE version 4.03 Grade ≤1 (Exception to this criterion: patients with any grade of alopecia and neuropathy grade≤ 2 are allowed to enter the study).
  • Patient with a Child-Pugh score B or C.
  • Patient has a history of non-compliance to medical regimen or inability to grant consent.
  • Pregnant or 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: Biomarker Window of Opportunity Study to Evaluate the Impact of Ribociclib on Head and Neck Squamous Cell Cancer

A window of opportunity study which would allow brief treatment of HPV negative SCCHN with a CDK4/6 inhibitor, in the pre-operative setting, with biomarker analyses of pre and post treatment tissue. Given that the standard treatment for this population is surgical resection, this would not impact or alter standard therapy for this population. The goal will be to learn more about the alterations in pRB1 levels, as well as other signaling markers, in order to be able to eventually plan a biomarker driven treatment study.

Being tested
Ribociclib
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.

  • RibociclibDrug

    Treatment with ribociclib [600mg] will be from Days 1-14, with surgical resection on Day 14. Labs (CBC, CMP, coagulation parameters) and an ECG will be checked once in a window defined by days 9-12.

Study groups in NCT03179956
Study groupRoleWhat they receive
RibociclibExperimentalNot described
Receives: Drug: Ribociclib

What is being measured

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

  1. Treatment with a CDK4/6 inhibitor, Ribociclib, decreases pRB1 levels in patients with SCCHN of the oral cavity, oropharynx and larynx.

    pre-treatment to post-treatment changes in pRB1 expression levels will be measured

    Measured: 1-2 months

Secondary outcomes (4)

  1. Change in pre-treatment to post-treatment levels of Ki67 in tissue samples from patients

    Measured: 2-3 months

  2. Change in pre-treatment to post-treatment levels of ERK1/2 in tissue samples from patients

    Measured: 2-3 months

  3. Change in pre-treatment to post-treatment levels of phosphorylated-ERK1/2 in tissue samples from patients

    Measured: 2-3 months

  4. Change in pre-treatment to post-treatment levels of p16 in tissue samples from patients

    Measured: 2-3 months

Timeline

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

  1. First posted7 Jun 2017
  2. Study start2 Apr 2018
  3. Primary completion12 Nov 2018
  4. Study completion10 Jan 2019

Why it stopped: Slow accrual

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
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179956
Sponsor's protocol ID
HN-089
Status last verified
Feb 2019
First submitted
6 Jun 2017
Last updated
25 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ribociclib in people with Squamous Cell Carcinoma of the Head and Neck, run by Fox Chase Cancer Center at 1 site 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 20 inclusion and 30 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: stopped early, as of the sponsor's last update on 25 Feb 2019. 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 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 was stopped early (reason given: Slow accrual). Results are not available in the source record.

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?

Treatment with a CDK4/6 inhibitor, Ribociclib, decreases pRB1 levels in patients with SCCHN of the oral cavity, oropharynx and larynx. (time frame: 1-2 months). 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 NCT03179956.

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 25 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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