A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

PHASE2CompletedINTERVENTIONAL
Enrollment

1,044

Participants

Timeline

Start Date

April 17, 2015

Primary Completion Date

May 31, 2019

Study Completion Date

March 24, 2021

Conditions
Colorectal Cancer
Interventions
DRUG

Cetuximab

500 mg/m\^2 via IV infusion on Day 1 of every 2-week cycle

DRUG

FOLFOX induction regimen

Administered per the Investigator's discretion in accordance with locally approved prescribing information.

DRUG

Fluoropyrimidine (5-FU/LV or capecitabine)

Per Investigator's discretion: 5-FU 1600-2400 mg/m\^2 administered via 46-hour IV infusion on Day 1 of every 2-week cycle and LV 400 mg/m\^2 administered via a 2-hour infusion on Day 1 every 2 weeks or 1000 mg/m\^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The chosen fluoropyrimidine should be administered in accordance with local prescribing information.

DRUG

Atezolizumab

800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle, or a fixed dose of 840 mg

DRUG

Vemurafenib

960 mg vermurafenib BID by mouth

DRUG

Bevacizumab

5 mg/kg bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle per local prescribing information

DRUG

Trastuzumab

Initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses by IV infusion on Day 1 of every 3-week treatment cycle

DRUG

Pertuzumab

Initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses by IV infusion on Day 1 of each 3-week treatment cycle

DRUG

Cobimetinib

60 mg orally once daily for 3 weeks followed by a 1-week treatment break

DRUG

5-FU/LV

1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle until disease progression per the Investigator's assessment using modified Response Evaluation Criteria in Solid Tumors or death from any cause, whichever occurs first. The fluoropyrimidine should be administered in accordance with local prescribing information.

DRUG

Capecitabine

1000 mg/m\^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The fluoropyrimidine should be administered in accordance with local prescribing information.

Trial Locations (154)

1000

Institut Jules Bordet X, Brussels

Institute of Oncology Ljubljana, Ljubljana

1070

Hospital Erasme, Brussels

2100

Rigshospitalet; Onkologisk Klinik, København Ø

2730

Herlev Hospital; Afdeling for Kræftbehandling, Herlev

3000

UZ Leuven Gasthuisberg, Leuven

3010

Hospital General Univ. de Alicante; Servicio de Oncologia, Alicante

4000

CHC MontLégia, Liège

Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium, Roskilde

5000

Odense Universitetshospital, Onkologisk Afdeling R, Odense C

7400

Regionshospitalet Gødstrup; Kræftafdelingen, Herning

8800

AZ Delta (Campus Rumbeke), Roeselare

10707

Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin

11000

Institute for Oncology and Radiology of Serbia; Clinic for Medical Oncology, Belgrade

11796

National Cancer Institute, Cairo

12559

DRK Kliniken Berlin Köpenick Darmzentrum, Berlin

14004

Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba

14080

Instituto Nacional de Cancerologia; Oncology, Mexico City

15706

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela

20080

Hospital de Donostia; Servicio de Oncologia Medica, Donostia / San Sebastian

20133

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milan

20141

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Studienzentrale der II. Med. Klinik, Hamburg

21680

MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken, Stade

22770

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne

23007

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaén

24121

Humanitas Gavazzeni;U.O. Oncologia Medica, Bergamo

25030

HOPITAL JEAN MINJOZ; Oncologie, Besançon

25198

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia, Lleida

25209

Ch De Montbeliard;Chir Generale Digestive, Montbéliard

28007

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

28046

Hospital Universitario La Paz; Servicio de Oncologia, Madrid

28222

Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Majadahonda

29011

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Málaga

29200

Hopital Augustin Morvan; Federation De Cancerologie, Brest

30029

Hopital Caremeau; Gastro Enterologie, Nîmes

30625

Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie, Hanover

31008

Hospital de Navarra; Servicio de Oncologia, Navarra

31059

Hopital Rangueil; Gastro Enterologie Et Nutrition, Toulouse

32005

Complejo Hospitalario de Orense; Servicio de Oncologia, Ourense

33011

Hospital Univ. Central de Asturias; Servicio de Oncologia, Oviedo

33098

Brüderkrankenhaus St. Josef, Paderborn

33600

Hopital Haut Leveque, Pessac

34093

Istanbul Uni Capa Medical Faculty; Inst. of Oncology, Istanbul

34890

Marmara Uni Faculty of Medicine; Medical Oncology, Istanbul

35100

Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir

35128

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima, Padua

35578

Klinikum Wetzlar-Braunfels, Klinik für Hämatologie/Onkologie und Palliativmedizin, Wetzlar

36043

Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH, Fulda

37000

Fundacion Rodolfo Padilla Padilla A.C., León

37134

A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U., Verona

38010

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia, Santa Cruz de Tenerife

39008

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia, Santander

39104

Onkologische Gemeinschaftspraxis, Magdeburg

39120

Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie, Mageburg

39130

Klinikum Magdeburg gGmbH Klinik für Allgemein- und Viszeralchirurgie, Magdeburg

41063

Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus, Mönchengladbach

43100

A.O. Universitaria Di Parma; Oncologia Medica, Parma

44625

Klinik der Ruhr-Uni Bochum; Marien-Hospital Herne, Herne

45659

Prosper-Hospital, Medizinische Klinik I, Recklinghausen

46010

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia

46014

Hospital General Universitario de Valencia; Servicio de oncologia, Valencia

46026

Hospital Universitario la Fe; Servicio de Oncologia, Valencia

47014

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola

48153

Gemeinschaftspraxis für Hämatologie und Onkologie, Münster

50009

Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia, Zaragoza

Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza

50139

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1, Florence

50226

PIOH PD Dr. R. Schnell ? Dr. H. Schulz ? Dr. M. Hellmann, Frechen

54290

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie, Trier

59037

Hopital Claude Huriez; Medecine Interne Oncologie, Lille

60488

Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie, Frankfurt

63003

Chu Estaing; Chir Generale Digestive A Et B, Clermont-Ferrand

66113

Praxis für Hämatologie & Onkologie, Saarbrücken

66822

Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel, Lebach

67200

ICANS, Strasbourg

68000

Oaxaca Site Management Organization, Oaxaca City

71013

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia, San Giovanni Rotondo

72764

Klinikum am Steinenberg / Ermstalklinik, Reutlingen

74078

SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm., Heilbronn

75571

Hopital Saint Antoine; Oncologie Medicale, Paris

76090

Cancerologia de Queretaro; Oncologia, Queretaro, Queretaro

78000

University Clinical Center of the Republic of Srpska, Banja Luka

80131

IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A, Napoli

81737

Städt. Klinikum München GmbH Klinikum Neuperlach Klinik f.Hämatologie u.Onkologie, München

84082

Clinique Sainte Catherine, Avignon

86021

Chu La Miletrie; Gastro Enterologie Endoscopies, Poitiers

86150

Hämatologie Onkologie im Zentrum MVZ GmbH, Augsburg

88212

Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg, Ravensburg

92300

Hôpital Franco-Britannique- Fondation Cognacq-Jay; Cancerologie, Levallois-Perret

93049

Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie, Regensburg

94805

Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif

115478

Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy, Moscow

450054

Bashkirian Republican Clinical Oncology Dispensary, Ufa

C1264AAA

Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología, Buenos Aires

F5300COE

Centro Oncologico Riojano Integral (CORI), La Rioja

R8500ACE

Clínica Viedma, Viedma Rio Negro

99010-260

Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia, Passo Fundo

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

14784-400

Hospital de Cancer de Barretos, Barretos

17210-120

Hospital Amaral Carvalho, Jaú

15090-000

Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*, São José do Rio Preto

01236-030

Instituto de Ensino e Pesquisa Sao Lucas - IEP, São Paulo

Unknown

Ain Shams University Hospital; Oncology, Cairo

01307

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie, Dresden

145 64

Agioi Anargyroi; 3Rd Dept. of Medical Oncology, Athens

711 10

Univ General Hosp Heraklion; Medical Oncology, Heraklion

455 00

Uni Hospital of Ioannina; Oncology Dept., Ioannina

265 04

University Hospital of Patras Medical Oncology, Pátrai

570 01

Thermi Clinic; Oncology Clinic, Thermi Thessalonikis

546 22

Bioclinic Thessaloniki, Thessaloniki

546 45

Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki

00168

Istituto Regina Elena; Oncologia Medica A, Rome

"Policlinico Universitario Agostino Gemelli; U.O.C. Oncologia Medica", Rome

1066 CX

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

NL 2900 AR

Ijsselland Ziekenhuis; Inwendige Geneeskunde, Capelle aan den IJssel

7416 SE

Deventer Ziekenhuis; Interne Geneeskunde, Deventer

3318 AT

Albert Schweitzer Ziekenhuis - loc Dordrecht, Dordrecht

5623 EJ

Catharina ZKHS; Inwendige Geneeskunde Afd., Eindhoven

3543 AZ

St. Antonius locatie Leidsche Rijn, Utrecht

8011 JW

Isala Klinieken, Zwolle

30-688

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Krakow

02-781

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Onkologii i Radioterapii,, Warsaw

3000-075

HUC; Servico de Oncologia Medica, Coimbra

1649-035

Hospital de Santa Maria; Servico de Oncologia Medica, Lisbon

833 10

Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E, Bratislava

058 01

POKO Poprad; Department of Oncology, Poprad

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

03203

Hospital General Universitario de Elche; Servicio de Oncologia, Elche

07014

Hospital Universitario Son Espases, Palma de Mallorca

08916

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona

08740

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de la Barca

221 85

Skånes University Hospital, Skånes Department of Onclology, Lund

171 76

Karolinska Hospital; Oncology - Radiumhemmet, Stockholm

01130

Acibadem University School of Medicine, Adana Hospital; General Surgery, Adana

06230

Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara

AB25 2ZN

Aberdeen Royal Infirmary; Medical Oncology Dept, Aberdeen

B9 5SS

Birmingham Heartlands Hospital, Birmingham

CM1 7ET

Broomfield Hospital; Oncology, Chelsmford

HU16 5JG

Castle Hill Hospital; The Queens Centre for Oncology and Haematology, Cottingham

SE1 9RT

Guys and St Thomas NHS Foundation Trust, Guys Hospital, London

SW3 6JJ

Royal Marsden Hospital; Dept of Med-Onc, London

M2O 4BX

Christie Hospital Nhs Trust; Medical Oncology, Manchester

HA6 2RN

Mount Vernon Hospital, Middlesex

RM7 0AG

Queen's Hospital, Romford

SO16 6YD

Southampton General Hospital; Medical Oncology, Southampton

SM2 5PT

Royal Marsden Hospital; Dept. of Medicine, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02291289 - A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) | Biotech Hunter | Biotech Hunter