125
Participants
Start Date
September 10, 2015
Primary Completion Date
July 19, 2018
Study Completion Date
September 7, 2022
palbociclib
Palbociclib will be supplied as capsules containing 75 mg, 100 mg, or 125 mg equivalents of palbociclib free base. Administered with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle.
Cetuximab
Cetuximab injection for IV infusion will be provided in 100 mg/50 mL, single-use vials, and 200 mg/100 mL, single-use vials. In Japan, cetuximab will be provided in 100 mg/20 mL, single-use vials. Administered, 400 mg/m2 initial dose as a 120-minute IV infusion followed by 250 mg/m2 weekly infused over 60 minutes.
Placebo
"Placebo for palbociclib will be indistinguishable from the palbociclib capsules and will be supplied as capsules matching in size and color the various palbociclib formulations.~Administered with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle."
Tri-Service General Hospital, Taipei
Taichung Veterans General Hospital, Taichung
National Cheng Kung University Hospital Department of Pathology, Tainan City
Debreceni Egyetem klinikai Koezpont Onkologiai Intezet, Debrecen
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet,Onkologiai Kozpont, Szolnok
Neuro CT Kft, Pécs
Pecsi Tudomanyegyetem, Klinikai Kozpont, Laboratoriumi, Pécs
Pecsi Tudomanyegyetem, Klinikai Kozpont,, Pécs
Institute for Oncology and Radiology of Serbia, Belgrade
Military Medical Academy, Belgrade
Instituto Nacional de Cancerologia, Mexico City
Podilskiy Regional Center of Oncology, Chemotherapy Department, Vinnytsia
Hospital Universitario 12 de Octubre, Madrid
Servicio de Oncologia, Pamplona
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza, Brzozów
Henry Joyce Cancer Clinic, Nashville
University Medical Center, lnc.:DBA University of Louisville Hospital, Louisville
China Medical University Hospital, Taichung
UC Health Physicians Office South, West Chester
University of Cincinnati Investigational Pharmacy, Cincinnati
University of Cincinnati Medical Center, Cincinnati
SI Dnipropetrovsk Medical Academy of MoH of Ukraine, Chair of Oncology and Medical Radiology, Dnipropetrovsk
CI Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council, Dnipropetrovsk
"Communal Institution Krivorizhskiy Oncology Dispensary of Dnipropetrovsk Regional Council,", Kryvyi Rih
Mayo Clinic, Rochester
"Communal Institution Chernivtsi Regional clinical oncology dispensary,", Chernivtsy
Barnes-Jewish Hospital, St Louis
Washington University School of Medicine, Siteman Cancer Center, St Louis
Siteman Cancer Center - South County, St Louis
Siteman Cancer Center - West County, Creve Coeur
Siteman Cancer Center, City of Saint Peters
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey
Cirugia y Ginecobstetricia de Oaxaca S.A de C.V Hospital Reforma, Oaxaca City
Oaxaca Site Management Organization S C, Oaxaca City
Diaz San Juan Noe, Imagenologia Siglo XXI San Felipe, Oaxaca City
Daniel Javier Mendez Lopez Imagen y Diagnostico Medico IDM, Oaxaca City
National Cheng Kung University Hospital, Tainan City
Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary, Antonivka
Regional Clinical Hospital, Department of microsurgery of otolaryngology organs, Ivano-Frankivsk
Fakultni nemocnice Olomouc, Lekarna, Olomouc
Istituto Nazionale Tumori Napoli, Napoli
Narodny onkologicky ustav, Bratislava
UC San Diego Medical Center - La Jolla (Thornton Hospital), La Jolla
UC San Diego Moores Cancer Center, La Jolla
UC San Diego Medical Center- Hillcrest, San Diego
State Budgetary Healthcare Institution of Arkhangelsk Region, Arkhangelsk
"FSBI National Medical Scientific Centre of Oncology n.a.N.N.Petrov of the MOH of Russia", Saint Petersburg
Centrul de Oncologie Sf. Nectarie SRL, Craiova
SC Oncolab SRL, Craiova
S.C. ONCOCENTER Oncologie Clinica S.R.L., Timișoara
"State Budgetary Healthcare Institution Oncology Center #2 of the Ministry of", Sochi
SC Medisprof SRL, Cluj-Napoca
State Autonomous Healthcare Institution Republican Clinical Oncology Dispensary of the Ministry, Kazan'
Spitalul Clinic Judetean de Urgenta Sibiu, Clinica Oncologie Medicala, Sibiu
Fakultni nemocnice Olomouc, Olomouc
Nemocnice Na Bulovce, Centralni laboratore Pavilon c. 8, Prague
Nemocnice Na Bulovce, Lekarna, Oddeleni Centralni pripravy, Prague
Nemocnice Na Bulovce, Ustav radiacni onkologie, Prague
Aichi cancer center Central hospital, Nagoya
National Cancer Center Hospital East, Kashiwa
Hokkaido University Hospital/Otolaryngology, Sapporo
Shizuoka Cancer Center, Sunto-gun
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii, Gdansk
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Oddzial Chemioterapii, Lodz
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Kliniczny Onkologii, Olsztyn
POKO Poprad, s.r.o., Poprad
Seoul National University Hospital, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Hospital Universitario Vall d'Hebron, Barcelona
"Clinic of SI Institute of Otolaryngology n.a. Prof. O.S. Kolomyichenka of NAMSU", Kyiv
Lead Sponsor
Pfizer
INDUSTRY