A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

564

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Gastric Cancer
Interventions
DRUG

5-Fluoruracil

Participants will receive 5-fluorouracil 400 milligrams per square meter (mg/m\^2) IV bolus and then 2400 mg/m\^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.

DRUG

Folinic acid

Participants will receive folinic acid 400 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.

DRUG

Onartuzumab

Participants will receive onartuzumab 10 mg/kg IV infusion on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.

DRUG

Oxaliplatin

Participants will receive oxaliplatin 85 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.

DRUG

Placebo

Participants will receive onartuzumab matching placebo on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.

Trial Locations (125)

100

Taipei

112

Taipei

404

Taichung

407

Taichung

500

Changhua

852

Hong Kong

2139

Sydney

2444

Port Macquarie

3000

Leuven

3128

Box Hill

4029

Herston

6004

Lucerne

6009

Nedlands

8000

Bruges

8063

Zurich

9100

Sint-Niklaas

10065

New York

10126

Turin

10330

Bangkok

10400

Bangkok

10700

Bangkok

12206

Albany

13273

Marseille

15000

Lopburi

20132

Milan

20133

Milan

20230

Aguascalientes

22767

Hamburg

22770

Edirne

25030

Besançon

25240

Erzurum

27710

Durham

28007

Madrid

28046

Madrid

29200

Brest

31059

Toulouse

33100

Udine

33705

St. Petersburg

33908

Fort Myers

35043

Marburg

37203

Nashville

39008

Santander

44280

Malatya

44805

Saint-Herblain

44892

Bochum

45122

Essen

45219

Cincinnati

49055

Angers

50009

Zaragoza

50139

Florence

55139

Samsun

57000

Chiang Rai

59100

Prato

Kuala Lumpur

60637

Chicago

64020

Monterrey

68000

Oaxaca City

68167

Mannheim

71640

Ludwigsburg

75475

Paris

75571

Paris

75674

Paris

75702

Tyler

78731

Austin

80218

Denver

81675

München

84918

Avignon

88100

Catanzaro

88996

Sabah

90095

Los Angeles

90110

Hat Yai

92118

Clichy

98684

Vancouver

153040

Ivanovo

169610

Singapore

300053

Tula

390011

Ryazan

443031

Samara

644013

Omsk

5262100

Ramat Gan

02903

Providence

02906

Providence

VIC 3165

East Bentleigh

L8L 2X2

Hamilton

M4N 3M5

Toronto

M5B 1N9

Toronto

M5G 1X5

Toronto

M5G 2M9

Toronto

H3T 1E2

Montreal

656 53

Brno

775 20

Olomouc

04103

Leipzig

01010

Guatemala City

Unknown

Hong Kong

Kaohisung

91120-01

Jerusalem

64239-06

Tel Aviv

00168

Rome

0834-02723

Panama City

85-796

Bydgoszcz

80-952

Gdansk

31-501

Krakow

20-081

Lublin

44-200

Rybnik

02-781

Warsaw

02841

Seoul

03080

Seoul

05505

Seoul

06351

Seoul

06591

Seoul

120-749

Seoul

135-720

Seoul

03203

Elche

08003

Barcelona

08035

Barcelona

08036

Barcelona

00112

Taipei

07070

Antalya

06100

Sıhhiye, Ankara

BS2 8ED

Bristol

CF14 2TL

Cardiff

SW3 6JJ

London

M2O 4BX

Manchester

SO16 6YD

Southampton

SM2 5PT

Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY