Gastric CancerPhase 3NCT01662869
A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer
A Phase 3 study testing 5-Fluoruracil, Folinic acid and Onartuzumab in people with Gastric Cancer, run by Hoffmann-La Roche at 125 sites in 24 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- 5-Fluoruracil, Folinic acid and Onartuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 564 participants
- Where
- 125 sitesin 24 countries
- Study dates
- Nov 2012to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
125 sites in 24 countries.
125 sites in 24 countries
United States15 sites
Study site
Albany, New York, 12206
Study site
Austin, Texas, 78731
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45219
Study site
Denver, Colorado, 80218
Study site
Durham, North Carolina, 27710
Study site
Fort Myers, Florida, 33908
Study site
Los Angeles, California, 90095
Study site
Nashville, Tennessee, 37203
Study site
New York, New York, 10065
Study site
Providence, Rhode Island, 02903
Study site
Providence, Rhode Island, 02906
Study site
St. Petersburg, Florida, 33705
Study site
Tyler, Texas, 75702
Study site
Vancouver, Washington, 98684
France11 sites
Study site
Angers, 49055
Study site
Avignon, 84918
Study site
Besançon, 25030
Study site
Brest, 29200
Study site
Clichy, 92118
Study site
Marseille, 13273
Study site
Paris, 75475
Study site
Paris, 75571
Study site
Paris, 75674
Study site
Saint-Herblain, 44805
Study site
Toulouse, 31059
Germany8 sites
Study site
Bochum, 44892
Study site
Essen, 45122
Study site
Hamburg, 22767
Study site
Leipzig, 04103
Study site
Ludwigsburg, 71640
Study site
Mannheim, 68167
Study site
Marburg, 35043
Study site
München, 81675
Italy8 sites
Study site
Catanzaro, Calabria, 88100
Study site
Florence, Tuscany, 50139
Study site
Milan, Lombardy, 20132
Study site
Milan, Lombardy, 20133
Study site
Prato, Tuscany, 59100
Study site
Rome, Lazio, 00168
Study site
Turin, Piedmont, 10126
Study site
Udine, Friuli Venezia Giulia, 33100
Spain8 sites
Study site
Barcelona, Barcelona, 08003
Study site
Barcelona, Barcelona, 08035
Study site
Barcelona, Barcelona, 08036
Study site
Elche, Alicante, 03203
Study site
Madrid, Madrid, 28007
Study site
Madrid, Madrid, 28046
Study site
Santander, Cantabria, 39008
Study site
Zaragoza, Zaragoza, 50009
South Korea7 sites
Study site
Seoul, 02841
Study site
Seoul, 03080
Study site
Seoul, 05505
Study site
Seoul, 06351
Study site
Seoul, 06591
Study site
Seoul, 120-749
Study site
Seoul, 135-720
Taiwan7 sites
Study site
Changhua, 500
Study site
Kaohisung
Study site
Taichung, 404
Study site
Taichung, 407
Study site
Taipei, 00112
Study site
Taipei, 100
Study site
Taipei, 112
Australia6 sites
Study site
Box Hill, Victoria, 3128
Study site
East Bentleigh, Victoria, VIC 3165
Study site
Herston, Queensland, 4029
Study site
Nedlands, Western Australia, 6009
Study site
Port Macquarie, New South Wales, 2444
Study site
Sydney, New South Wales, 2139
Canada6 sites
Study site
Hamilton, Ontario, L8L 2X2
Study site
Montreal, Quebec, H3T 1E2
Study site
Toronto, Ontario, M4N 3M5
Study site
Toronto, Ontario, M5B 1N9
Study site
Toronto, Ontario, M5G 1X5
Study site
Toronto, Ontario, M5G 2M9
Poland6 sites
Study site
Bydgoszcz, 85-796
Study site
Gdansk, 80-952
Study site
Krakow, 31-501
Study site
Lublin, 20-081
Study site
Rybnik, 44-200
Study site
Warsaw, 02-781
Thailand6 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Bangkok, 10700
Study site
Chiang Rai, 57000
Study site
Hat Yai, 90110
Study site
Lopburi, 15000
Turkey (Türkiye)6 sites
Study site
Antalya, 07070
Study site
Edirne, 22770
Study site
Erzurum, 25240
Study site
Malatya, 44280
Study site
Samsun, 55139
Study site
Sıhhiye, Ankara, 06100
United Kingdom6 sites
Study site
Bristol, BS2 8ED
Study site
Cardiff, CF14 2TL
Study site
London, SW3 6JJ
Study site
Manchester, M2O 4BX
Study site
Southampton, SO16 6YD
Study site
Sutton, SM2 5PT
Russia5 sites
Study site
Ivanovo, 153040
Study site
Omsk, 644013
Study site
Ryazan, 390011
Study site
Samara, 443031
Study site
Tula, 300053
Belgium3 sites
Study site
Bruges, 8000
Study site
Leuven, 3000
Study site
Sint-Niklaas, 9100
Israel3 sites
Study site
Jerusalem, 91120-01
Study site
Ramat Gan, 5262100
Study site
Tel Aviv, 64239-06
Mexico3 sites
Study site
Aguascalientes, 20230
Study site
Monterrey, 64020
Study site
Oaxaca City, 68000
About this study
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
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.
- Conditions
- Gastric Cancer
- Being tested
- 5-Fluoruracil, Folinic acid, Onartuzumab, Oxaliplatin, Placebo
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluoruracilDrug
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.
Folinic acidDrug
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.
OnartuzumabDrug
Also called MetMAb, RO5490258, PRO143966
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.
OxaliplatinDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Onartuzumab+mFOLFOX6 | Experimental | 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. Receives: Drug: 5-Fluoruracil; Drug: Folinic acid; Drug: Onartuzumab; Drug: Oxaliplatin |
| Placebo+mFOLFOX6 | Placebo comparator | 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. Receives: Drug: 5-Fluoruracil; Drug: Folinic acid; Drug: Oxaliplatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup
Measured: Baseline until death (up to approximately 38 months overall)
OS in the Intent-To-Treat (ITT) Population
Measured: Baseline until death (up to approximately 38 months overall)
Secondary outcomes (14)
Duration of Response, as Assessed by Investigator Using RECIST v1.1
Measured: 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)
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
Measured: 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)
Percentage of Participants with Adverse Events
Measured: Baseline up to approximately 38 months
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) of Onartuzumab
Measured: 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)
Change from Baseline in ATAs Level of Onartuzumab
Measured: 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)
Minimum Serum Concentration of Onartuzumab (Cmin)
Measured: 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)
Maximum Serum Concentration (Cmax) of Onartuzumab
Measured: 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)
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
Measured: Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 38 months overall)
PFS, as Assessed by Investigator Using RECIST v1.1 in ITT Population
Measured: 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)
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
Measured: 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)
Percentage of Participants with a Tumor Response of CR or PR as Determined by the Investigator Using RECIST v1.1 in ITT Population
Measured: 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)
European Organization for Research and Treatment Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (EORTC QLQ-C30) Score
Measured: Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months
EORTC QLQ-Gastric cancer Specific Quality of Life Questionnaire (EORTC QLQ-STOC22) Score
Measured: Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months
European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Score
Measured: Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662869
- Sponsor's protocol ID
- YO28322
- Other IDs
- 2012-001402-23
- Status last verified
- Nov 2016
- First submitted
- 8 Aug 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
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.
PubMed 27918764
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01662869
- Acronym / sponsor ID
- YO28322
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onartuzumab+mFOLFOX6 | Experimental | Drug: 5-Fluoruracil, Drug: Folinic acid, Drug: Onartuzumab, Drug: OxaliplatinParticipants 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. |
| Placebo+mFOLFOX6 | Placebo comparator | Drug: 5-Fluoruracil, Drug: Folinic acid, Drug: Oxaliplatin, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-FluoruracilParticipants 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 | Onartuzumab+mFOLFOX6, Placebo+mFOLFOX6 |
| Folinic acidParticipants 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+mFOLFOX6, Placebo+mFOLFOX6 |
| OnartuzumabAlso: MetMAb, RO5490258, PRO143966Participants 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 | Onartuzumab+mFOLFOX6 |
| OxaliplatinParticipants 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 | Onartuzumab+mFOLFOX6, Placebo+mFOLFOX6 |
| PlaceboParticipants 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. | Drug | Placebo+mFOLFOX6 |
Primary outcome
Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup
Time frame: Baseline until death (up to approximately 38 months overall)
OS in the Intent-To-Treat (ITT) Population
Time frame: Baseline until death (up to approximately 38 months overall)
14 secondary outcomes
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)
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)
Percentage of Participants with Adverse Events
Time frame: Baseline up to approximately 38 months
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 27918764Shah 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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Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
125 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-Fluoruracil, Folinic acid and Onartuzumab in people with Gastric Cancer, run by Hoffmann-La Roche at 125 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in United States, France, Germany, Italy, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup (time frame: Baseline until death (up to approximately 38 months overall)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01662869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.