- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145312
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.
July 15, 2018 updated by: Yonsei University
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 Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Byung Chul Cho
- Phone Number: +82 (2) 2228-0880
- Email: CBC1971@yuhs.ac
Study Locations
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Seoul, Korea, Republic of, 03722
- Recruiting
- Yonsei Cancer Center at Yonsei University Medical Center
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Contact:
- Byung Chul Cho, M.D., Ph.D.
- Phone Number: 82-2-2228-0880
- Email: CBC1971@yuhs.ac
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BYL719
BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds.
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BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate
Time Frame: 8 weeks of BYL 719 administered as therapy
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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.
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8 weeks of BYL 719 administered as therapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: 24 months
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24 months
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Progression-free survival (PFS)
Time Frame: 24 months
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24 months
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Overall Response Rate (ORR)
Time Frame: 24 months
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24 months
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Time to progression (TPP)
Time Frame: 24 months
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24 months
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Drug toxicity and safety analysis
Time Frame: 24 months
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24 months
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Quality of life assessment
Time Frame: 24 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
May 1, 2019
Study Registration Dates
First Submitted
May 19, 2014
First Submitted That Met QC Criteria
May 19, 2014
First Posted (Estimate)
May 22, 2014
Study Record Updates
Last Update Posted (Actual)
July 18, 2018
Last Update Submitted That Met QC Criteria
July 15, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2014-0147
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
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Vanderbilt-Ingram Cancer CenterBoehringer Ingelheim; National Comprehensive Cancer NetworkWithdrawnSquamous Cell Carcinoma | Recurrent Squamous Cell Carcinoma of the Head or Neck | Metastatic Squamous Cell Carcinoma of the Head or Neck
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Head and Neck Squamous Cell Carcinoma | Metastatic Squamous Cell Carcinoma of the Hypopharynx | Metastatic Squamous Cell Carcinoma of the Larynx | Metastatic Squamous Cell Carcinoma of the Oral Cavity | Metastatic Squamous Cell Carcinoma of the Oropharynx | Recurrent Hypopharyngeal... and other conditionsUnited States
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Regeneron PharmaceuticalsSanofiCompletedRecurrent Squamous Cell Carcinoma of Head | Recurrent Squamous Cell Carcinoma of Neck | Metastatic Squamous Cell Carcinoma of Head | Metastatic Squamous Cell Carcinoma NeckKorea, Republic of, United Kingdom
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BioAtla, Inc.RecruitingHead and Neck Cancer | Metastatic Cancer | Squamous Cell Carcinoma of Head and Neck | Recurrent Squamous Cell Carcinoma of the Head and Neck | Metastatic Squamous Cell Carcinoma of the Head and NeckUnited States
-
AmgenCompletedCarcinoma | Cancer | Head and Neck Cancer | Metastatic Cancer | Oncology | Tumors | Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck | Squamous Cell Carcinoma | Metastases
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Glenn J. HannaImmunityBio, Inc.RecruitingHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Recurrent Head and Neck Squamous Cell Carcinoma | Recurrent Head and Neck Cancer | Metastatic Head and Neck Cancer | Metastatic Head-and-neck Squamous-cell CarcinomaUnited States
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AstraZenecaPRA Health SciencesCompletedRecurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and NeckUnited States, Belgium, Canada, France, Spain, Korea, Republic of, Hungary, Malaysia, United Kingdom, Taiwan, Germany, Georgia, Israel, Czechia
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AIO-Studien-gGmbHBristol-Myers SquibbCompletedCarcinoma, Squamous Cell of Head and Neck | Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckGermany
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Shanghai Miracogen Inc.RecruitingRecurrent or Metastatic Squamous Cell Carcinoma of Head and NeckChina
-
AstraZenecaCompletedRecurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHNUnited States, France, Italy, Spain, Belgium, Czechia, Romania, Taiwan, Korea, Republic of, Brazil, Hungary, Japan, Russian Federation, Australia, Germany, Israel, Serbia, Bulgaria, Ukraine, Argentina, Poland, Chile, Croatia, Georgia
Clinical Trials on BYL719
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Columbia UniversityCompleted
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Novartis PharmaceuticalsCompleted
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Peter MacCallum Cancer Centre, AustraliaNovartis PharmaceuticalsCompletedMetastatic Breast CancerAustralia
-
Novartis PharmaceuticalsAvailablePIK3CA-Related Overgrowth Spectrum (PROS)
-
Lawson Health Research InstituteActive, not recruitingHead and Neck Squamous Cell CancerCanada
-
Novartis PharmaceuticalsActive, not recruitingPIK3CA-related Overgrowth Spectrum (PROS)Spain, France, Ireland, United States
-
New Mexico Cancer Care AllianceNo longer available
-
Novartis PharmaceuticalsCompletedRelapsed and Refractory Multiple MyelomaItaly, Germany, Singapore, Australia, United States
-
Array BioPharmaCompletedAML | Advanced and Selected Solid Tumors | High Risk and Very High Risk MDSUnited States, Australia, Italy, Spain, France, Switzerland, United Kingdom
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Novartis PharmaceuticalsTerminatedRecurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell CarcinomaFrance, Taiwan, United States, Australia, Canada, Hong Kong, Singapore, Korea, Republic of, Netherlands