The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
BURAN
1 other identifier
interventional
487
17 countries
162
Brief Summary
The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 head-and-neck-cancer
Started Dec 2020
162 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2020
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedStudy Start
First participant enrolled
December 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2025
CompletedNovember 17, 2025
November 1, 2025
4.9 years
March 18, 2020
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
To assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC
Overall survival will be measured from time of randomization until death from any cause. The analysis will occur when all patients have been randomized and followed for 12 months.
Secondary Outcomes (5)
Progression free survival
PFS will be assessed up to 24 months after all patients are randomized
Overall Response Rate
ORR will be assessed for all patients 6 months after randomization is complete.
Health Related Quality of Life (QoL): Time to Definitive deterioration of Quality of Life as assessed by EORTC C30 questionnaire
Assessments will be made from randomization until treatment discontinuation
Safety and Tolerability of Buparlisib in combination with Paclitaxel compared with Paclitaxel alone as Measured by Number of Participants Experiencing Adverse Events (AEs).
From screening until 4 weeks following treatment discontinuation
Pharmacokinetics of Buparlisib: plasma concentration-time profile of Buparlisib during 15 days of treatment
Day 0 to Day 15 sparse sampling
Study Arms (2)
Buparlisib & Weekly Paclitaxel
EXPERIMENTALDrug: Patients will receive 100 mg (2 x 50 mg) buparlisib hard gel capsule administered orally, once daily starting on Day 1 of Treatment Cycle 1, Drug: Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason.
Weekly Paclitaxel
ACTIVE COMPARATORPatients will receive weekly paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason.
Interventions
Eligibility Criteria
You may qualify if:
- Aged ≥18 years old.
- Able to provide informed consent obtained before any trial related activities and according to local guidelines.
- Patient has histologically and/or cytologically-confirmed HNSCC.
- Patient has archival or new tumor tissue for the analysis of biomarkers and confirmation of HPV status (if unknown). One tumor block (preferred) or a recommended minimum of 5 unstained slides for patients with known HPV status (for tumor DNA characterization) or a recommended minimum of 10 slides for patients whose HPV status is unknown (5 slides for HPV testing plus 5 slides needed for biomarker testing). Enrollment in the study is contingent on confirmation of the availability of an adequate amount of tumor tissue, except in rare special circumstances, which must be reviewed and approved by the sponsor.
- Patient has either progressive or recurrent disease after treatment with PDL1/PD1 based therapy for recurrent or metastatic disease:
- PDLl/PD1 therapy alone for metastatic (monotherapy) disease
- PDL1/PD1 in combination with chemotherapy for metastatic and recurrent disease
- PDL1/PD1 used for metastatic disease, after or prior to receiving a platinum agent for locally advanced or metastatic disease.
- \. Patient has received no more than two prior lines of systemic treatment for HNSCC (single agent chemotherapy used as a radiosensitizer is not counted as a prior line of therapy).
- Patient has measurable disease as determined per RECIST version 1.1. If the only site of measurable disease is a previously irradiated lesion, documented progression of disease and a four-week period since radiotherapy completion is required.
- Patient has adequate bone marrow function and organ function as shown by the following:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L.
- Hemoglobin ≥9 g/dL (which may be reached by transfusion).
- Platelets ≥100 x 109/L (which may be reached by transfusion).
- International normalized ratio (INR) ≤1.5.
- +10 more criteria
You may not qualify if:
- Patients meeting any of the following criteria will not be eligible for participation in the study:
- Patient has received previous treatment with any protein kinase B (PKB/AKT), mammalian target of rapamycin (mTOR) inhibitors, or phosphatidylinositol 3 kinase (PI3K) pathway inhibitors.
- Patient received treatment with a taxane as part of prior treatment for metastatic disease.
- Patient has symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases may participate in this study. Patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy) and must be on a stable low dose of corticosteroid therapy. Radiosurgery must have been completed at least 14 days prior to start of study treatment.
- Patient has received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment or who have adverse events which have not recovered to grade 1 or better from previous chemotherapy treatment (except alopecia, autoimmune endocrine events must be stable and controlled).
- Patient has grade ≥ 2 neuropathy, colitis, pneumonitis, , and uncontrolled endocrinopathies (e.g., hypothyroidism, diabetes with hemoglobin A1c \> 8%) from previous treatment
- Patient has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
- Patient is currently receiving increasing or chronic treatment (\>5 days) with corticosteroids or another immunosuppressive agent. The following uses of corticosteroids are permitted: single doses; standard premedication for paclitaxel, topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops, or local injections (e.g., intra-articular), or \< 10 mg prednisolone or equivalent.
- Patient is being treated at start of study treatment with any of the following drugs:
- Drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4) including herbal medications (see Table 16).
- Drugs with a known risk of inducing Torsades de Pointes. Note: The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to starting study treatment is allowed.
- Patient is currently receiving warfarin or other coumarin-derived anti-coagulant, for treatment, prophylaxis, or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), fondaparinux or new oral anticoagulants (NOACs) is allowed.
- Patient has a known hypersensitivity and/or contraindication to paclitaxel, standard premedication for paclitaxel, or other products containing Cremophor®.
- Patient has other concurrent severe and/or uncontrolled medical conditions that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (e.g., active or uncontrolled severe infection, chronic active hepatitis, immunocompromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc).
- Patient has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory).
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (162)
City of Hope
Duarte, California, 91010, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, 06511, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington University School of Medicine
St Louis, Missouri, 63130, United States
NYU Langone
New York, New York, 10016, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45219, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Hollings Cancer Center
Charleston, South Carolina, 29425, United States
West Cancer Center
Germantown, Tennessee, 38138, United States
Hope Cancer Center, UT Health East Texas
Tyler, Texas, 75701, United States
Fundacion Cenit para la Investigacion en Neurociencias
Buenos Aires, 1125, Argentina
Centro de Investigacion Pergamino SA - Clinica Pergamino S.A.
Buenos Aires, B2700CPM, Argentina
Instituto de Investigaciones Metabólicas (IDIM) // Instituto de Investigaciones Metabólicas S.A.
Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina
IONC SRL- Instituto Oncológico de Córdoba
Córdoba, X5002HWE, Argentina
Fundacion CORI para la Investigacion y Prevencion del Cáncer
La Rioja, F5300COE, Argentina
Centro para la Atencion Integral del Paciente Oncologico - CAIPO
San Miguel de Tucumán, T4000GTB, Argentina
Princess Alexandra Hospital
Brisbane, 4102, Australia
Universitair Ziekenhuis Gent UZ Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
Clinique CHC MontLégia
Liège, 4000, Belgium
Clinique Saint-Pierre dOttignies CSPO
Ottignies, 1340, Belgium
CHUM
Montreal, H2X 0C2, Canada
CancerCare Manitoba
Winnipeg, R3E 0V9, Canada
Beijing Tongren Hospital
Beijing, 100176, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004, China
Hunan Cancer Hospital
Changsha, 410000, China
Xiangya Hospital Central South University
Changsha, 410000, China
Sichuan Cancer Hospital
Chengdu, 610042, China
Affiliated Cancer Hospital of Chongqing University
Chongqing, 400000, China
The First Affiliated Hospital of CQMU
Chongqing, 400042, China
Sun Yat-sen University Cancer Center
Guangzhou, 510000, China
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, 510095, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Anhui Provincial Cancer Hospital
Hefei, 230031, China
Shandong Provincial Tumor Hospital
Jinan, 250000, China
Yunnan Cancer Hospital
Kunming, 650000, China
Cancer Hospital affiliated to Guangxi Medical University
Naning, 530021, China
Shanghai Dongfang Hospital
Shanghai, 310115, China
Tianjin Cancer Hospital
Tianjin, 300202, China
Henan Cancer Hospital
Zhengzhou, 450000, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, 519000, China
Centre hospitalier Universitaire de Bordeaux
Bordeaux, 33075, France
Centre Franois Baclesse
Caen, 14000, France
Centre Leon Berard
Lyon, 69008, France
Hopital de la Timone
Marseille, 13005, France
Institut regional du Cancer de Montpellier
Montpellier, 34298, France
LHopital prive du Confluent Nantes
Nantes, 44277, France
Clinique Hartmann
Neuilly-sur-Seine, 92200, France
Hôpital St-Louis
Paris, 75010, France
Hopital La Pitie Salpetriere
Paris, 75013, France
Hopital Tenon
Paris, 75970, France
CHP Saint-Grégoire
Saint-Grégoire, 35760, France
Institut de cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54500, France
Uniklinik RWTH Aachen
Aachen, 52074, Germany
Universitaetsklinikum Bonn
Bonn, 53127, Germany
University Hospital Essen
Essen, 45147, Germany
Franziskus Hospital
Georgsmarienhütte, 49124, Germany
HNO-Klinik des Universitats-Klinikums Giessen
Giessen, 35392, Germany
Universitatsmedizin Greifswald - KoR
Greifswald, 17489, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Marienkrankenhaus Hamburg
Hamburg, 22045, Germany
Hannover Medical School
Hanover, 30625, Germany
Universitatsklinikum Leipzig
Leipzig, 04103, Germany
UNIVERSITÄTSMEDIZIN Mainz III. Klinik/Poliklinik
Mainz, 55131, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
University of Pecs Department of Oncotherapy
Pécs, 7624, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Azienda Ospedaliera Universitaria S.Orsola-Malpighi
Bologna, 40138, Italy
ASST Spedali Civili Brescia
Brescia, 25123, Italy
Istituto di Candiolo IRCCS
Candiolo, 10060, Italy
IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori
Cesena, Italy
A.O. S. Croce e Carle
Cuneo, 12100, Italy
Azienda Ospedaliero Universitaria Careggi - Firenze
Florence, 50134, Italy
Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliera San Paolo Polo Universitario
Milan, 20142, Italy
INT IRCCS Fondazione G.Pascale
Napoli, 80131, Italy
A.O.U. "Maggiore della Carita"- S.C.D.U Oncologiac
Novara, 28100, Italy
Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone" U.O.C. Oncologia Medica
Palermo, 90127, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, 43126, Italy
IRCCS Maugeri Pavia
Pavia, 27100, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
AOU San Giovanni di Dio e Ruggi D'Aragona, Università degli Studi di Salerno
Salerno, 84131, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100, Italy
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
Sondrio, 23100, Italy
AO Card. G. Panico
Tricase, 73039, Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine, 33100, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Hyogo Cancer Center
Akashi-shi, 673-8558, Japan
National Cancer Center Hospital
Chūōku, 104-0045, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Saitama Medical University International Medical Center
Hidaka, 350-1298, Japan
Kagawa University Hospital
Kita-gun, 761-0793, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Aichi Cancer Center
Nagoya, 464-8681, Japan
Kindai University Hospital
Osaka Sayama-shi, 589-8511, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
National University Corporation Tohoku University, Tohoku University Hospital
Sendai, 980-8574, Japan
Showa University Hospital
Shinagawa-Ku, 142-8666, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Gliwice, 44-102, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
Warsaw, 02-781, Poland
Kosin University Gospel Hospital
Busan, 49267, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 2841, South Korea
Asan Medical Center
Seoul, 5505, South Korea
The Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, 6591, South Korea
Korea University Guro Hospital
Seoul, 8308, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Fundacion Oncologico de Galicia Jos Antonio Quiroga y Pieyro
A Coruña, 15009, Spain
Institut Catala d Oncologia Badalona
Badalona, 08916, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Vall dHebron Institute of Oncology (VHIO)
Barcelona, 08035, Spain
Hospital Clinic Barcelona
Barcelona, 08036, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Duran i Reynals - Institut Catala dOncologia ICO
L'Hospitalet de Llobregat, 08908, Spain
Hospital Universitario Severo Ochoa
Leganés, 28911, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Madrid, 30120, Spain
Hospital General Universitario Gregorio Maran
Madrid, Spain
Hospital Puerta de Hierro- Majadahonda
Majadahonda, 28220, Spain
Hospital Regional de Malaga
Málaga, 29010, Spain
Hospital de Navarra
Pamplona, 31008, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Universitario Santiago de Compostela
Santiago de Compostela, 15706, Spain
Valme Hospital Medical Oncology Department
Seville, 41014, Spain
Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hospital Clinico Universitario Valencia - INCLIVA
Valencia, 46010, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
Chang Gung Memorial Hospital-KaohSiung
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704017, Taiwan
Chi Mei Medical Center Liouying
Tainan, 73657, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital-LinKou
Taoyuan District, 33342, Taiwan
Edinburgh Cancer Center
Edinburgh, EH4 2XU, United Kingdom
Beatson Oncology Centre
Glasgow, G12 0YN, United Kingdom
University College London Hospitals
London, NW1 2BU, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust - Sutton
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Director, Global Operations
Adlai Nortye USA Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2020
First Posted
April 8, 2020
Study Start
December 12, 2020
Primary Completion
November 2, 2025
Study Completion
November 2, 2025
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share