Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

March 6, 2014

Primary Completion Date

October 24, 2016

Study Completion Date

April 26, 2017

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Sym004 (12 mg/kg)

Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

DRUG

Sym004 (9/6 mg/kg)

Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

OTHER

Best Supportive Care (BSC)

BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.

DRUG

Fluorouracil (5-FU)

5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

DRUG

Capecitabine

Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

Trial Locations (54)

1070

ULB Hôpital Erasme, Brussels

1100

SMZ Süd - Kaiser Franz Josef Spital Wien, Vienna

1145

Uzsoki Utcai Korhaz, Budapest

1200

Cliniques Universitaires Saint-Luc, Brussels

3000

UZ Leuven, Leuven

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc

4400

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

5000

Clinique et Maternité Sainte-Elisabeth, Namur

Jasz-Nagykun-Szolnok Megyei Korhaz-Rendelointezet, Szolnok

5530

CHU Mont-Godinne, Yvoir

7000

CHU Ambroise Paré, Mons

9000

Universitair Ziekenhuis Gent, Ghent

16132

Azienda Ospedaliero Universitaria San Martino, Genova

20162

Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan

21079

Centre Georges François Leclerc, Dijon

28007

Hospital General Universitario Gregorio Marañon, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

31059

CHU de Toulouse - Hôpital Rangueil, Toulouse

33006

Hospital Universitario Central de Asturias, Oviedo

33075

Groupe Hospitalier Saint André - Hôpital Saint André, Bordeaux

33705

Florida Cancer Specialists, St. Petersburg

33916

Florida Cancer Specialists-Broadway, Fort Myers

34952

Hematology - Oncology Associates of Treasure Coast, Port Saint Lucie

35042

CRLCC Eugene Marquis, Rennes

35128

IOV - Istituto Oncologico Veneto IRCCS, Padua

41013

Hospital Universitario Virgen del Rocio, Seville

44805

ICO - Site René Gauducheau, Saint-Herblain

49933

ICO - Site Paul Papin, Angers

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona

60590

Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt

63110

Washington University School of Medicine, St Louis

65807

Mercy Research, Springfield

69008

Centre Léon Bérard, Lyon

75702

Texas Oncology, P.A., Tyler

80138

Seconda Università degli Studi di Napoli, Napoli

84000

Institut Sainte Catherine, Avignon

89074

Comprehensive Cancer Centers of Nevada, Henderson

90033

USC Norris Comprehensive Cancer Center, Los Angeles

92123

Sharp Memorial Hospital, San Diego

197022

"St. Petersburg SHI City Clinical Oncology Dispensary", Saint Petersburg

644013

"BHI of Omsk region Clinical Oncology Dispensary", Omsk

01307

Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden

00168

Policlinico Universitario Agostino Gemelli, Roma

03039

Presidio Ospedaliero SS. Trinità Sora, Sora

05100

Azienda Ospedaliera S. Maria Di Terni, Terni

10-228

SPZOZ MSW zWarmińsko-MazurskimCen.Onko.wOlsztynie, Olsztyn

61-866

Wielkopolskie Centrum Onkologii, Poznan

87-100

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun

02-781

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warsaw

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

08908

ICO l´Hospitalet - Hospital Duran i Reynals, Barcelona

All Listed Sponsors
lead

Symphogen A/S

INDUSTRY

NCT02083653 - Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter