87
Participants
Start Date
December 22, 2015
Primary Completion Date
January 11, 2018
Study Completion Date
February 21, 2018
Patritumab
Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks
Cetuximab
Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Cisplatin
Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
Carboplatin
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
Placebo
Placebo to match patritumab
Institut Jules Bordet, Brussels
Orszagos Onkologiai Intezet, Budapest
Univeristair Ziekenhuis Antwerpen, Edegem
UZ Leuven, Leuven
Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum, Debrecen
Josa Andras Oktatokorhaz, Nyíregyháza
Bacs-Kiskun Megyei Korhaz, Kecskemét
CHU Hopital de la Timone, Marseille
Hopital Saint Joseph, Marseille
Medizinische Hochschule Hannover, Hanover
Centre Hospitalier de Bordeaux - Hôpital Saint André, Bordeaux
Centre de Cancerologie du Grand Montpellier, Montpellier
Institut de Cancerologie de l'Ouest, Saint-Herblain
Institut de Cancerologie de l'Ouest, Angers
Hopital Croix-Rousse, Lyon
Centre Leon Berard, Lyon
Institut Curie, Paris
Klinikum der Universitat Munchen, München
Gustave Roussy, Villejuif
Centrul de Oncologie Sfantul Nectarie, Craiova
Medisprof SRL, Cluj-Napoca
Institutul Regional de Oncologie Iasi, Iași
Charite Universitatsmedizin Berlin, Berlin
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz
"Przychodnia Lekarska KOMED", Konin
Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi, Lodz
University College London Hospitals NHS Foundation Trust - University College Hospital, London
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital, London
The Royal Marsden NHS Foundation Trust, London
Weston Park Hospital, Sheffield
The Shrewsbury and Telford Hospital NHS Trust, Shrewsbury
Southampton General Hospital, Southampton
The Royal Marsden NHS Foundation Trust, Sutton
Lead Sponsor
Daiichi Sankyo
INDUSTRY