Spots Global Cancer Trial Database for Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
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Trial Identification
Brief Title: Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
Official Title: A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 2 STUDY OF PALBOCICLIB PLUS CETUXIMAB VERSUS CETUXIMAB FOR THE TREATMENT OF HUMAN PAPILLOMAVIRUS-NEGATIVE, CETUXIMAB-NAÏVE PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AFTER FAILURE OF ONE PRIOR PLATINUM-CONTAINING CHEMOTHERAPY REGIMEN
Study ID: NCT02499120
Study Description
Brief Summary: The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC San Diego Medical Center - La Jolla (Thornton Hospital), La Jolla, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
UC San Diego Medical Center- Hillcrest, San Diego, California, United States
University Medical Center, lnc.:DBA University of Louisville Hospital, Louisville, Kentucky, United States
Mayo Clinic, Rochester, Minnesota, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Siteman Cancer Center, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Siteman Cancer Center, Saint Peters, Missouri, United States
University of Cincinnati Investigational Pharmacy, Cincinnati, Ohio, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
UC Health Physicians Office South, West Chester, Ohio, United States
Henry Joyce Cancer Clinic, Nashville, Tennessee, United States
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Olomouc, Lekarna, Olomouc, , Czechia
Nemocnice Na Bulovce, Centralni laboratore Pavilon c. 8, Praha 8, , Czechia
Nemocnice Na Bulovce, Lekarna, Oddeleni Centralni pripravy, Praha 8, , Czechia
Nemocnice Na Bulovce, Ustav radiacni onkologie, Praha 8, , Czechia
Debreceni Egyetem klinikai Koezpont Onkologiai Intezet, Debrecen, , Hungary
Neuro CT Kft, Pecs, , Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont, Laboratoriumi, Pecs, , Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont,, Pecs, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet,Onkologiai Kozpont, Szolnok, , Hungary
Istituto Nazionale Tumori Napoli, Napoli, , Italy
Aichi cancer center Central hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Hokkaido University Hospital/Otolaryngology, Sapporo, Hokkaido, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Instituto Nacional de Cancerologia, Mexico, Distrito Federal, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo LEON, Mexico
Cirugia y Ginecobstetricia de Oaxaca S.A de C.V Hospital Reforma, Oaxaca, Oaxaca DE Juarez, Mexico
Diaz San Juan Noe, Imagenologia Siglo XXI San Felipe, Oaxaca, Oaxaca DE Juarez, Mexico
Daniel Javier Mendez Lopez Imagen y Diagnostico Medico IDM, Oaxaca, Oaxaca DE Juarez, Mexico
Oaxaca Site Management Organization S C, Oaxaca, , Mexico
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza, Brzozow, , Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii, Gdansk, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Oddzial Chemioterapii, Lodz, , Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Kliniczny Onkologii, Olsztyn, , Poland
SC Medisprof SRL, Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sf. Nectarie SRL, Craiova, Dolj, Romania
SC Oncolab SRL, Craiova, Dolj, Romania
S.C. ONCOCENTER Oncologie Clinica S.R.L., Timisoara, Timis, Romania
Spitalul Clinic Judetean de Urgenta Sibiu, Clinica Oncologie Medicala, Sibiu, , Romania
State Budgetary Healthcare Institution of Arkhangelsk Region, Arkhangelsk, Arkhangelsk Region, Russian Federation
State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of, Sochi, Krasnodar Region, Russian Federation
State Autonomous Healthcare Institution Republican Clinical Oncology Dispensary of the Ministry, Kazan, Tatarstan Republic, Russian Federation
FSBI "National Medical Scientific Centre of Oncology n.a.N.N.Petrov" of the MOH of Russia, Saint-Petersburg, , Russian Federation
Institute for Oncology and Radiology of Serbia, Belgrade, , Serbia
Military Medical Academy, Belgrade, , Serbia
Narodny onkologicky ustav, Bratislava, , Slovakia
POKO Poprad, s.r.o., Poprad, , Slovakia
Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Taichung Veterans General Hospital, Taichung City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Cheng Kung University Hospital Department of Pathology, Tainan, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary, Antonivka, Kherson Region, Ukraine
Communal Institution "Chernivtsi Regional clinical oncology dispensary",, Chernivtsy, , Ukraine
SI Dnipropetrovsk Medical Academy of MoH of Ukraine, Chair of Oncology and Medical Radiology, Dnipropetrovsk, , Ukraine
CI Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council, Dnipropetrovsk, , Ukraine
Regional Clinical Hospital, Department of microsurgery of otolaryngology organs, Ivano-Frankivsk, , Ukraine
Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council,, Kriviy Rig, , Ukraine
Clinic of SI "Institute of Otolaryngology n.a. Prof. O.S. Kolomyichenka of NAMSU", Kyiv, , Ukraine
Podilskiy Regional Center of Oncology, Chemotherapy Department, Vinnytsia, , Ukraine
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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