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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
5-Fluoruracil
Folinic acid
Onartuzumab
Oxaliplatin
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable to curative therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy greater than (>) 3 months
  • Presence of tissue sample for IHC assay of MET receptor and HER2 status
  • Tumor (primary or metastatic lesion) defined as MET-positive by IHC
  • Measurable disease or non-measurable but evaluable disease, according to the RECIST v1.1; Participants with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial
  • For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  • For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin

Exclusion Criteria:

  • HER2-positive tumor (primary tumor or metastasis)
  • Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
  • Prior treatment with investigational drugs that target the human growth factor (HGF) or MET pathway
  • History of another malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancer
  • Pregnancy or lactation
  • Receipt of an investigational drug within 28 days prior to study start
  • Clinically significant gastrointestinal abnormalities, apart from gastric cancer, including uncontrolled inflammatory gastrointestinal diseases
  • Significant history of cardiac disease
  • Significant vascular disease
  • Serious active infection at the time of randomization, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
  • Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
  • Radiotherapy within 4 weeks before start of study treatment
  • Major surgery within 4 weeks before start of study treatment, without complete recovery
  • Any condition (psychological, geographical) that does not permit compliance with study and follow-up procedures
  • Peripheral neuropathy
  • Prior unanticipated severe reaction to fluoropyrimidine therapy
  • Known sensitivity or contraindication to any component of study treatment
  • Active gastrointestinal bleeding

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Onartuzumab+mFOLFOX6

Placebo+mFOLFOX6

Arm Description

Participants will receive onartuzumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion + mFOLFOX6 (oxaliplatin, folinic acid, and 5-fluoruracil) regimen. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with onartuzumab. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with onartuzumab will continue treatment with onartuzumab until disease progression, unacceptable toxicity, or death.

Participants will receive onartuzumab matching placebo + mFOLFOX6. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with placebo. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with placebo will continue treatment with placebo until disease progression, unacceptable toxicity, or death.

Outcomes

Primary Outcome Measures

Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup
OS in the Intent-To-Treat (ITT) Population

Secondary Outcome Measures

Duration of Response, as Assessed by Investigator Using RECIST v1.1
Percentage of Participants with a Tumor Response of CR or PR or Stable Disease (SD, Maintained for At Least 6 Months) as Determined by the Investigator Using RECIST v1.1
Percentage of Participants with Adverse Events
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) of Onartuzumab
Change from Baseline in ATAs Level of Onartuzumab
Minimum Serum Concentration of Onartuzumab (Cmin)
Maximum Serum Concentration (Cmax) of Onartuzumab
Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in MET IHC 2+/3+ Participant Subgroup
PFS, as Assessed by Investigator Using RECIST v1.1 in ITT Population
Percentage of Participants with a Tumor Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator Using RECIST v1.1 in MET IHC 2+/3+ Participant Subgroup
Percentage of Participants with a Tumor Response of CR or PR as Determined by the Investigator Using RECIST v1.1 in ITT Population
European Organization for Research and Treatment Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (EORTC QLQ-C30) Score
EORTC QLQ-Gastric cancer Specific Quality of Life Questionnaire (EORTC QLQ-STOC22) Score
European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Score

Full Information

First Posted
August 8, 2012
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01662869
Brief Title
A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer
Official Title
A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With 5-Fluorouracil, Folinic Acid, and Oxaliplatin (mFOLFOX6) in Patients With Metastatic HER2-Negative, MET-Positive Gastroesophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until disease progression, unacceptable toxicity, participant or physician decision to discontinue treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
564 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Onartuzumab+mFOLFOX6
Arm Type
Experimental
Arm Description
Participants will receive onartuzumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion + mFOLFOX6 (oxaliplatin, folinic acid, and 5-fluoruracil) regimen. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with onartuzumab. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with onartuzumab will continue treatment with onartuzumab until disease progression, unacceptable toxicity, or death.
Arm Title
Placebo+mFOLFOX6
Arm Type
Placebo Comparator
Arm Description
Participants will receive onartuzumab matching placebo + mFOLFOX6. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with placebo. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with placebo will continue treatment with placebo until disease progression, unacceptable toxicity, or death.
Intervention Type
Drug
Intervention Name(s)
5-Fluoruracil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Folinic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Onartuzumab
Other Intervention Name(s)
MetMAb, RO5490258, PRO143966
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup
Time Frame
Baseline until death (up to approximately 38 months overall)
Title
OS in the Intent-To-Treat (ITT) Population
Time Frame
Baseline until death (up to approximately 38 months overall)
Secondary Outcome Measure Information:
Title
Duration of Response, as Assessed by Investigator Using RECIST v1.1
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
Title
Percentage of Participants with a Tumor Response of CR or PR or Stable Disease (SD, Maintained for At Least 6 Months) as Determined by the Investigator Using RECIST v1.1
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
Title
Percentage of Participants with Adverse Events
Time Frame
Baseline up to approximately 38 months
Title
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) of Onartuzumab
Time Frame
Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1 and 4, (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)
Title
Change from Baseline in ATAs Level of Onartuzumab
Time Frame
Baseline (pre-dose [within 1 hour before infusion start] on Cycle 1 Day 1), pre-dose on Cycle 4 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)
Title
Minimum Serum Concentration of Onartuzumab (Cmin)
Time Frame
Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1, 2 and 4, 30 minutes after end of infusion (duration of infusion = 60 minutes) on Cycle 1 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)
Title
Maximum Serum Concentration (Cmax) of Onartuzumab
Time Frame
Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1, 2 and 4, 30 minutes after end of infusion (duration of infusion = 60 minutes) on Cycle 1 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)
Title
Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in MET IHC 2+/3+ Participant Subgroup
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 38 months overall)
Title
PFS, as Assessed by Investigator Using RECIST v1.1 in ITT Population
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
Title
Percentage of Participants with a Tumor Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator Using RECIST v1.1 in MET IHC 2+/3+ Participant Subgroup
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
Title
Percentage of Participants with a Tumor Response of CR or PR as Determined by the Investigator Using RECIST v1.1 in ITT Population
Time Frame
Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
Title
European Organization for Research and Treatment Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (EORTC QLQ-C30) Score
Time Frame
Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months
Title
EORTC QLQ-Gastric cancer Specific Quality of Life Questionnaire (EORTC QLQ-STOC22) Score
Time Frame
Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months
Title
European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Score
Time Frame
Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable to curative therapy Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Life expectancy greater than (>) 3 months Presence of tissue sample for IHC assay of MET receptor and HER2 status Tumor (primary or metastatic lesion) defined as MET-positive by IHC Measurable disease or non-measurable but evaluable disease, according to the RECIST v1.1; Participants with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin Exclusion Criteria: HER2-positive tumor (primary tumor or metastasis) Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization) Prior treatment with investigational drugs that target the human growth factor (HGF) or MET pathway History of another malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancer Pregnancy or lactation Receipt of an investigational drug within 28 days prior to study start Clinically significant gastrointestinal abnormalities, apart from gastric cancer, including uncontrolled inflammatory gastrointestinal diseases Significant history of cardiac disease Significant vascular disease Serious active infection at the time of randomization, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment Infection with human immunodeficiency virus, hepatitis B, or hepatitis C Radiotherapy within 4 weeks before start of study treatment Major surgery within 4 weeks before start of study treatment, without complete recovery Any condition (psychological, geographical) that does not permit compliance with study and follow-up procedures Peripheral neuropathy Prior unanticipated severe reaction to fluoropyrimidine therapy Known sensitivity or contraindication to any component of study treatment Active gastrointestinal bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
VIC 3165
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1N9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Brno
ZIP/Postal Code
656 53
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Angers
ZIP/Postal Code
49055
Country
France
City
Avignon
ZIP/Postal Code
84918
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Brest
ZIP/Postal Code
29200
Country
France
City
Clichy
ZIP/Postal Code
92118
Country
France
City
Marseille
ZIP/Postal Code
13273
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
St Herblain
ZIP/Postal Code
44805
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Bochum
ZIP/Postal Code
44892
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
City
Marburg
ZIP/Postal Code
35043
Country
Germany
City
München
ZIP/Postal Code
81675
Country
Germany
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Jerusalem
ZIP/Postal Code
91120-01
Country
Israel
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239-06
Country
Israel
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
City
Prato
State/Province
Toscana
ZIP/Postal Code
59100
Country
Italy
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-749
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
City
Sabah
ZIP/Postal Code
88996
Country
Malaysia
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
City
Panama
ZIP/Postal Code
0834-02723
Country
Panama
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Luzern
ZIP/Postal Code
6004
Country
Switzerland
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Kaohisung
Country
Taiwan
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
City
Lopburi
ZIP/Postal Code
15000
Country
Thailand
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
City
Edirne
ZIP/Postal Code
22770
Country
Turkey
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
City
Sıhhiye, ANKARA
ZIP/Postal Code
06100
Country
Turkey
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27918764
Citation
Shah MA, Bang YJ, Lordick F, Alsina M, Chen M, Hack SP, Bruey JM, Smith D, McCaffery I, Shames DS, Phan S, Cunningham D. Effect of Fluorouracil, Leucovorin, and Oxaliplatin With or Without Onartuzumab in HER2-Negative, MET-Positive Gastroesophageal Adenocarcinoma: The METGastric Randomized Clinical Trial. JAMA Oncol. 2017 May 1;3(5):620-627. doi: 10.1001/jamaoncol.2016.5580.
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A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer

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