Spots Global Cancer Trial Database for The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
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Trial Identification
Brief Title: The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
Official Title: The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Study ID: NCT04338399
Conditions
Interventions
Study Description
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.
Detailed Description: This study is to assess the impact on overall survival of the combination of Buparlisib and paclitaxel compared to paclitaxel alone in patients with 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Yale University, Yale Cancer Center, New Haven, Connecticut, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Kentucky, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
NYU Langone, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Cincinnati Cancer Center, Cincinnati, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center, Charleston, South Carolina, United States
West Cancer Center, Germantown, Tennessee, United States
Hope Cancer Center, UT Health East Texas, Tyler, Texas, United States
Fundacion Cenit para la Investigacion en Neurociencias, Buenos Aires, , Argentina
Centro de Investigacion Pergamino SA - Clinica Pergamino S.A., Buenos Aires, , Argentina
Instituto de Investigaciones MetabĂłlicas (IDIM) // Instituto de Investigaciones MetabĂłlicas S.A., Ciudad Autonoma de Buenos Aire, , Argentina
IONC SRL- Instituto OncolĂłgico de CĂłrdoba, CĂłrdoba, , Argentina
Fundacion CORI para la Investigacion y Prevencion del CĂĄncer, La Rioja, , Argentina
Centro para la Atencion Integral del Paciente Oncologico - CAIPO, Tucuman, , Argentina
Princess Alexandra Hospital, Brisbane, , Australia
Universitair Ziekenhuis Gent UZ Gent, Ghent, , Belgium
Universitair Ziekenhuis Brussel, Jette, , Belgium
Clinique CHC MontLĂ©gia, Liege, , Belgium
Clinique Saint-Pierre dOttignies CSPO, Ottignies, , Belgium
CHUM, Montreal, , Canada
CancerCare Manitoba, Winnipeg, , Canada
Beijing Tongren Hospital, Beijing, , China
The First Affiliated Hospital of Bengbu Medical College, Bengbu, , China
Hunan Cancer Hospital, Changsha, , China
Xiangya Hospital Central South University, Changsha, , China
Sichuan Cancer Hospital, Chengdu, , China
Affiliated Cancer Hospital of Chongqing University, Chongqing, , China
The First Affiliated Hospital of CQMU, Chongqing, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Anhui Provincial Cancer Hospital, Hefei, , China
Shandong Provincial Tumor Hospital, Jinan, , China
Yunnan Cancer Hospital, Kunming, , China
Cancer Hospital affiliated to Guangxi Medical University, Naning, , China
Shanghai Dongfang Hospital, Shanghai, , China
Tianjin Cancer Hospital, Tianjin, , China
Henan Cancer Hospital, Zhengzhou, , China
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, , China
Centre hospitalier Universitaire de Bordeaux, Bordeaux, , France
Centre Franois Baclesse, Caen, , France
Centre Leon Berard, Lyon, , France
Hopital de la Timone, Marseille, , France
Institut regional du Cancer de Montpellier, Montpellier, , France
LHopital prive du Confluent Nantes, Nantes, , France
Clinique Hartmann, Neuilly Sur Seine, , France
HĂŽpital St-Louis, Paris, , France
Hopital La Pitie Salpetriere, Paris, , France
Hopital Tenon, Paris, , France
CHP Saint-Grégoire, Saint-Grégoire, , France
Institut de cancerologie de Lorraine, VandĆuvre-lĂšs-Nancy, , France
Uniklinik RWTH Aachen, Aachen, , Germany
Universitaetsklinikum Bonn, Bonn, , Germany
University Hospital Essen, Essen, , Germany
Franziskus Hospital, GeorgsmarienhĂŒtte, , Germany
HNO-Klinik des Universitats-Klinikums Giessen, Giessen, , Germany
Universitatsmedizin Greifswald - KoR, Greifswald, , Germany
Universitatsklinikum Hamburg Eppendorf, Hamburg, , Germany
Marienkrankenhaus Hamburg, Hamburg, , Germany
Hannover Medical School, Hannover, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
UNIVERSITĂTSMEDIZIN Mainz III. Klinik/Poliklinik, Mainz, , Germany
Queen Mary Hospital, Hong Kong, , Hong Kong
Orszagos Onkologiai Intezet, Budapest, , Hungary
University of Pecs Department of Oncotherapy, PĂ©cs, , Hungary
Tolna Megyei Balassa Janos Korhaz, SzekszĂĄrd, , Hungary
Azienda Ospedaliera Universitaria S.Orsola-Malpighi, Bologna, , Italy
ASST Spedali Civili Brescia, Brescia, , Italy
Istituto di Candiolo IRCCS, Candiolo, , Italy
IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori, Cesena, , Italy
A.O. S. Croce e Carle, Cuneo, , Italy
Azienda Ospedaliero Universitaria Careggi - Firenze, Firenze, , Italy
Azienda Ospedaliera San Paolo Polo Universitario, Milano, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
INT IRCCS Fondazione G.Pascale, Napoli, , Italy
A.O.U. "Maggiore della Carita"- S.C.D.U Oncologiac, Novara, , Italy
Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone" U.O.C. Oncologia Medica, Palermo, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
IRCCS Maugeri Pavia, Pavia, , Italy
IRCCS Istituto Clinico Humanitas, Rozzano, , Italy
AOU San Giovanni di Dio e Ruggi D'Aragona, UniversitĂ degli Studi di Salerno, Salerno, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena, , Italy
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio, Sondrio, , Italy
AO Card. G. Panico, Tricase, , Italy
Azienda Sanitaria Universitaria Integrata di Udine, Udine, , Italy
Azienda Ospedaliera Universitaria Integrata Verona, Verona, , Italy
Hyogo Cancer Center, Akashi-shi, , Japan
National Cancer Center Hospital, Chuo Ku, , Japan
Kyushu University Hospital, Fukuoka shi, , Japan
Saitama Medical University International Medical Center, Hidaka, , Japan
Kagawa University Hospital, Kita-gun, , Japan
Kobe University Hospital, Kobe, , Japan
The Cancer Institute Hospital of JFCR, Koto-Ku, , Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, , Japan
Aichi Cancer Center, Nagoya, , Japan
Kindai University Hospital, Osaka Sayama-shi, , Japan
Hokkaido University Hospital, Sapporo, , Japan
National University Corporation Tohoku University, Tohoku University Hospital, Sendai, , Japan
Showa University Hospital, Shinagawa-Ku, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
Kosin University Gospel Hospital, Busan, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul ST. Mary's Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon-si, , Korea, Republic of
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Gliwice, , Poland
Narodowy Instytut Onkologii im. Marii SkĆodowskiej-Curie, Warszawa, , Poland
Fundacion Oncologico de Galicia Jos Antonio Quiroga y Pieyro, A Coruña, , Spain
Institut Catala d Oncologia Badalona, Badalona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Vall dHebron Institute of Oncology (VHIO), Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital Universitario de Burgos, Burgos, , Spain
Hospital Reina Sofia, CĂłrdoba, , Spain
Hospital Duran i Reynals - Institut Catala dOncologia ICO, Hospitalet de Llobregat, , Spain
Complejo Hospitalario de Jaen, Jaén, , Spain
Hospital Universitario Severo Ochoa, Leganés, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca, Madrid, , Spain
Hospital General Universitario Gregorio Maran, Madrid, , Spain
Hospital Puerta de Hierro- Majadahonda, Majadahonda, , Spain
Hospital Regional de Malaga, MĂĄlaga, , Spain
Hospital de Navarra, Pamplona, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Universitario Santiago de Compostela, Santiago De Compostela, , Spain
Valme Hospital Medical Oncology Department, Sevilla, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Clinico Universitario Valencia - INCLIVA, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
Chang Gung Memorial Hospital-KaohSiung, Kaohsiung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi Mei Medical Center Liouying, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital-LinKou, Taoyuan, , Taiwan
Edinburgh Cancer Center, Edinburgh, , United Kingdom
Beatson Oncology Centre, Glasgow, , United Kingdom
University College London Hospitals, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust - Sutton, Sutton, , United Kingdom
Contact Details
Name: Senior Director, Global Operations
Affiliation: Adlai Nortye USA Inc.
Role: STUDY_DIRECTOR
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