CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

August 28, 2017

Study Completion Date

October 4, 2017

Conditions
Carcinoma, Squamous Cell of Head and Neck
Interventions
DRUG

CetuGEX™

60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration

DRUG

Cetuximab

400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration

DRUG

Chemotherapy

Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)

Trial Locations (34)

1000

Glycotope-contracted Research Facility, Brussels

1200

Glycotope-contracted Research Facility, Brussels

2650

Glycotope-contracted Research Facility, Antwerp

2781

Glycotope-contracted Research Facility, Warsaw

9000

Glycotope-contracted Research Facility, Ghent

12203

Glycotope-contracted Research Facility, Berlin

20142

Gycotope-contracted Research Facility, Milan

20246

Glycotope-contracted Research Facility, Hamburg

27100

Glycotope-contracted Research Facility, Pavia

28050

Glycotope-contracted Research Facility, Madrid

28911

Glycotope-contracted Research Facility, Madrid

30625

Glycotope-contracted Research Facillity, Hanover

44805

Glycotope-contracted Research Facility, Saint-Herblain

45122

Glycotope-contracted Research Facility, Essen

46009

Glycotope-contracted Research Facility, Valencia

52074

Glycotope-contracted Research Facility, Aachen

59020

Glycotope-contracted Research Facility, Lille

69008

Glycotope-contracted Research Facility, Lyon

84918

Glycotope-contracted Research Facility, Avignon

100011

Glycotope-contracted Research Facility, Ploieşti

200385

Glycotope-contracted Research Facility, Craiova

300167

Glycotope-contracted Research Facility, Timișoara

300239

Glycotope-contracteed Research Facility, Timișoara

400015

Glycotope-contracted Research Facility, Clui-Napoca

410469

Glycotope-contracted Research Facility, Oradea

500091

Glycotope-contracted Research Facility, Brasov

06189

Glycotope-contracted Research Facility, Nice

01307

Glycotope-contracted Research Facility, Dresden

04103

Glycotope-contracted Research Facility, Leipzig

85-796

Glycotope-contracted Research Facility, Bydgoszcz

Unknown

Glycotope-contracted Research Facility, Krakow

93-513

Glycotope-contracted Research Facility, Lodz

20-090

Glycotope-contracted Research Facility, Lublin

08036

Glycotope-contracted Research Facility, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Glycotope GmbH

INDUSTRY