Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

PHASE2TerminatedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

December 22, 2015

Primary Completion Date

January 11, 2018

Study Completion Date

February 21, 2018

Conditions
Head and Neck Neoplasms
Interventions
DRUG

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

DRUG

Cetuximab

Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly

DRUG

Cisplatin

Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles

DRUG

Carboplatin

Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles

DRUG

Placebo

Placebo to match patritumab

Trial Locations (34)

1000

Institut Jules Bordet, Brussels

1122

Orszagos Onkologiai Intezet, Budapest

2650

Univeristair Ziekenhuis Antwerpen, Edegem

3000

UZ Leuven, Leuven

3526

Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc

4032

Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum, Debrecen

4400

Josa Andras Oktatokorhaz, Nyíregyháza

6000

Bacs-Kiskun Megyei Korhaz, Kecskemét

13005

CHU Hopital de la Timone, Marseille

13008

Hopital Saint Joseph, Marseille

30625

Medizinische Hochschule Hannover, Hanover

33075

Centre Hospitalier de Bordeaux - Hôpital Saint André, Bordeaux

34070

Centre de Cancerologie du Grand Montpellier, Montpellier

44805

Institut de Cancerologie de l'Ouest, Saint-Herblain

49055

Institut de Cancerologie de l'Ouest, Angers

69004

Hopital Croix-Rousse, Lyon

69373

Centre Leon Berard, Lyon

75248

Institut Curie, Paris

81377

Klinikum der Universitat Munchen, München

94805

Gustave Roussy, Villejuif

200347

Centrul de Oncologie Sfantul Nectarie, Craiova

400058

Medisprof SRL, Cluj-Napoca

700483

Institutul Regional de Oncologie Iasi, Iași

12200/12203

Charite Universitatsmedizin Berlin, Berlin

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz

62-500

"Przychodnia Lekarska KOMED", Konin

93-513

Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi, Lodz

NW1 2PG

University College London Hospitals NHS Foundation Trust - University College Hospital, London

SE1 7EH

Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

S10 2SJ

Weston Park Hospital, Sheffield

SY3 8XQ

The Shrewsbury and Telford Hospital NHS Trust, Shrewsbury

SO16 6YD

Southampton General Hospital, Southampton

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY