Recurrent or Metastatic Squamous Cell Carcinoma of Head and NeckPhase 2NCT02145312
An Open Label, Single Arm, Multicenter Phase II Study of BYL719 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Who Failed to Respond to Platinum-based Therapy.
A Phase 2 study testing BYL719 in people with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck, run by Yonsei University at 1 site in South Korea.
Trial summary
One promising approach to the treatment of cancer is inhibition or modulating the crucial signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is an alpha specific I PI3K inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- BYL719
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2016to May 2019
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed recurrent or metastatic squamous-cell carcinoma of head and neck (SCCHN), except nasopharyngeal carcinoma
- 18 years of age or older
- Patients must have progressive disease after one or two prior chemotherapy regimens including platinum-based chemotherapy given for the treatment of recurrent and/or metastatic disease, or within 6 months after concurrent chemoradiation (with or without induction chemotherapy) given as a definitive treatment.
- Life expectancy of at least 12 weeks
- Ineligibility for local therapy (surgery or radiation for curative intent)
- At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
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- ECOG performance score of 0-2
- Availability of tissue samples (archival tissue or rebiopsied tissues) for molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
- Adequate organ function and laboratory parameters as defined by:
- Absolute neutrophil count (ANC) ≥1.5x109/L
- Hemoglobin (Hgb) ≥ 9 g/dl (which may be reached by transfusion)
- Platelets (PLT) ≥ 100 x 109/L (which may be reached by transfusion)
- AST/SCOT and ALT/SGPT ≤ 2.5xULN (upper limit of normal) or ≤ 5 x ULN if liver metastases are present
- Serum bilirubin ≤ 1.5 x ULN
- Serum creatinib ≤ 1.5 x ULN or calculated or directly measured CrCl ≥ 50% LLN (lower limit of normal)
- Fasting plasma glucose (FPG) < 140 mg/dL/7.8mmol/L
Who cannot join
- Prior treatment with PI3K pathway inhibitors
- Nasopharyngeal carcinoma
- Uncontrolled, untreated brain metastasis. Patients with treated/controlled and asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases ≥ 28 days (must include radiotherapy and/or surgery) and, if on corticosteroid therapy, should be receiving a stable low dose (e.g. dexamethasone 4 mg or equivalent dose of another corticosteroid for at least 14 days before start of study treatment).
- Surgery, chemotherapy or irradiation within 3 weeks of study entry
- Concomitant chemotherapy, hormonal therapy or immunotherapy
- Clinically significant cardiac disease or impaired cardiac function, such as:
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- Congestive heart failure (CHF) requiring treatment (New Yort Heart Association (NYHA) Grade ≥ 2), left ventricular ejection fraction (LVEF) < 50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled arterial hypertension defined by blood pressure > 140/100 mmHg at rest (average of 3 consecutive readings)
- History or current evidence of clinically significant cardiac arrhythmias, arterial fibrillation and/or conduction abnormality, e.g. congenical long QT syndrome, high grade/complete AV-blockage
- Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting), < 3 months prior to screening
- QT interval adjusted according to Fredericia (QTcF) > 480 msec on screening ECG
- Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with FPG ≥ 140 mg/dL/7.8mmol/L, or history of documented steroid-induced diabetes mellitus.
- Patient who cannot take the oral drug
- 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)
- Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment.
- Previous or concomitant malignant disease, except adequately treated basal cell cancer of the skin or cervical cancer in situ, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated > 3 years prior study entry
- Pregnant woman, Breast-feeding woman
- Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial (infection/inflammation, intestinal obstruction, social/psychological complications).
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, 03722
Byung Chul Cho, M.D., Ph.D., 82-2-2228-0880, CBC1971@yuhs.ac
About this study
One promising approach to the treatment of cancer is inhibition or modulating the crucial signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is an alpha specific I PI3K inhibitor. It showed significant, concentration dependent cell growth inhibition and induction of apoptosis. We suggest multicenter single arm phase II study to determine anti-tumor effects of BYL719 in patients with recurrent and/or metastatic SCCHN who failed to prior chemotherapy regimens. Enrollment will be done in 5 or more clinical trial centers in Korea. Primary objective is to evaluate disease control rate (DCR) at 8 weeks of BYL719, and the efficacy will be evaluated by the investigators analysis based on RECIST version 1.1.
- Being tested
- BYL719
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BYL719Drug
BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds.
| Study group | Role | What they receive |
|---|---|---|
| BYL719 | Experimental | BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds. Receives: Drug: BYL719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
The primary objective of this study is to evaluate disease control rate (DCR) at 8 weeks of BYL719 administered as therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma, comparing with historical control. Efficacy evaluation will be based on RECIST version 1.1. DCR will be expressed percent and 95% confidence interval.
Measured: 8 weeks of BYL 719 administered as therapy
Secondary outcomes (6)
Overall Response Rate (ORR)
Measured: 24 months
Progression-free survival (PFS)
Measured: 24 months
Overall survival (OS)
Measured: 24 months
Time to progression (TPP)
Measured: 24 months
Drug toxicity and safety analysis
Measured: 24 months
Quality of life assessment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start1 Oct 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145312
- Sponsor's protocol ID
- 4-2014-0147
- Status last verified
- Jul 2018
- First submitted
- 19 May 2014
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm, Multicenter Phase II Study of BYL719 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Who Failed to Respond to Platinum-based Therapy.
- ClinicalTrials.gov ID
- NCT02145312
- Acronym / sponsor ID
- 4-2014-0147
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 22 May 2014 (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.
One promising approach to the treatment of cancer is inhibition or modulating the crucial signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is an alpha specific I PI3K inhibitor. It showed significant, concentration dependent cell growth inhibition and induction of apoptosis. We suggest multicenter single arm phase II study to determine anti-tumor effects of BYL719 in patients with recurrent and/or metastatic SCCHN who failed to prior chemotherapy regimens. Enrollment will be done in 5 or more clinical trial centers in Korea. Primary objective is to evaluate disease control rate (DCR) at 8 weeks of BYL719, and the efficacy will be evaluated by the investigators analysis based on RECIST version 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BYL719 | Experimental | Drug: BYL719BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed recurrent or metastatic squamous-cell carcinoma of head and neck (SCCHN), except nasopharyngeal carcinoma
- 18 years of age or older
- Patients must have progressive disease after one or two prior chemotherapy regimens including platinum-based chemotherapy given for the treatment of recurrent and/or metastatic disease, or within 6 months after concurrent chemoradiation (with or without induction chemotherapy) given as a definitive treatment.
- Life expectancy of at least 12 weeks
- Ineligibility for local therapy (surgery or radiation for curative intent)
Key exclusion criteria (17 listed)
- Prior treatment with PI3K pathway inhibitors
- Nasopharyngeal carcinoma
- Uncontrolled, untreated brain metastasis. Patients with treated/controlled and asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases ≥ 28 days (must include radiotherapy and/or surgery) and, if on corticosteroid therapy, should be receiving a stable low dose (e.g. dexamethasone 4 mg or equivalent dose of another corticosteroid for at least 14 days before start of study treatment).
- Surgery, chemotherapy or irradiation within 3 weeks of study entry
- Concomitant chemotherapy, hormonal therapy or immunotherapy
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 |
|---|---|---|
| BYL719BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds. | Drug | BYL719 |
Primary outcome
Disease control rate
Time frame: 8 weeks of BYL 719 administered as therapy
The primary objective of this study is to evaluate disease control rate (DCR) at 8 weeks of BYL719 administered as therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma, comparing with historical control. Efficacy evaluation will be based on RECIST version 1.1. DCR will be expressed percent and 95% confidence interval.
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Time to progression (TPP)
Time frame: 24 months
Drug toxicity and safety analysis
Time frame: 24 months
Quality of life assessment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BYL719 in people with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck, run by Yonsei University at 1 site in South Korea.
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 16 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byung Chul Cho (+82 (2) 2228-0880, CBC1971@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (time frame: 8 weeks of BYL 719 administered as therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2018.