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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001402-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluoruracil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup | Baseline until death (up to approximately 38 months overall) | |
| OS in the Intent-To-Treat (ITT) Population | Baseline until death (up to approximately 38 months overall) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response, as Assessed by Investigator Using RECIST v1.1 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90095 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27918764 | Derived | 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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| Folinic acid | Drug | 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. |
|
| Onartuzumab | Drug | 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. |
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| Oxaliplatin | Drug | 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. |
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| Placebo | Drug | 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. |
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| 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 | Baseline up to approximately 38 months |
| Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) of Onartuzumab | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months |
| Denver |
| Colorado |
| 80218 |
| United States |
| Fort Myers | Florida | 33908 | United States |
| St. Petersburg | Florida | 33705 | United States |
| Chicago | Illinois | 60637 | United States |
| Albany | New York | 12206 | United States |
| New York | New York | 10065 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Providence | Rhode Island | 02903 | United States |
| Providence | Rhode Island | 02906 | United States |
| Nashville | Tennessee | 37203 | United States |
| Austin | Texas | 78731 | United States |
| Tyler | Texas | 75702 | United States |
| Vancouver | Washington | 98684 | United States |
| Port Macquarie | New South Wales | 2444 | Australia |
| Sydney | New South Wales | 2139 | Australia |
| Herston | Queensland | 4029 | Australia |
| Box Hill | Victoria | 3128 | Australia |
| East Bentleigh | Victoria | VIC 3165 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Bruges | 8000 | Belgium |
| Leuven | 3000 | Belgium |
| Sint-Niklaas | 9100 | Belgium |
| Hamilton | Ontario | L8L 2X2 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5B 1N9 | Canada |
| Toronto | Ontario | M5G 1X5 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Brno | 656 53 | Czechia |
| Olomouc | 775 20 | Czechia |
| Angers | 49055 | France |
| Avignon | 84918 | France |
| Besançon | 25030 | France |
| Brest | 29200 | France |
| Clichy | 92118 | France |
| Marseille | 13273 | France |
| Paris | 75475 | France |
| Paris | 75571 | France |
| Paris | 75674 | France |
| Saint-Herblain | 44805 | France |
| Toulouse | 31059 | France |
| Bochum | 44892 | Germany |
| Essen | 45122 | Germany |
| Hamburg | 22767 | Germany |
| Leipzig | 04103 | Germany |
| Ludwigsburg | 71640 | Germany |
| Mannheim | 68167 | Germany |
| Marburg | 35043 | Germany |
| München | 81675 | Germany |
| Guatemala City | 01010 | Guatemala |
| Hong Kong | 852 | Hong Kong |
| Hong Kong | Hong Kong |
| Jerusalem | 91120-01 | Israel |
| Ramat Gan | 5262100 | Israel |
| Tel Aviv | 64239-06 | Israel |
| Catanzaro | Calabria | 88100 | Italy |
| Udine | Friuli Venezia Giulia | 33100 | Italy |
| Rome | Lazio | 00168 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Milan | Lombardy | 20133 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Florence | Tuscany | 50139 | Italy |
| Prato | Tuscany | 59100 | Italy |
| Sabah | Sabah | 88996 | Malaysia |
| Kuala Lumpur | 59100 | Malaysia |
| Aguascalientes | 20230 | Mexico |
| Monterrey | 64020 | Mexico |
| Oaxaca City | 68000 | Mexico |
| Panama City | 0834-02723 | Panama |
| Bydgoszcz | 85-796 | Poland |
| Gdansk | 80-952 | Poland |
| Krakow | 31-501 | Poland |
| Lublin | 20-081 | Poland |
| Rybnik | 44-200 | Poland |
| Warsaw | 02-781 | Poland |
| Ivanovo | 153040 | Russia |
| Omsk | 644013 | Russia |
| Ryazan | 390011 | Russia |
| Samara | 443031 | Russia |
| Tula | 300053 | Russia |
| Singapore | 169610 | Singapore |
| Seoul | 02841 | South Korea |
| Seoul | 03080 | South Korea |
| Seoul | 05505 | South Korea |
| Seoul | 06351 | South Korea |
| Seoul | 06591 | South Korea |
| Seoul | 120-749 | South Korea |
| Seoul | 135-720 | South Korea |
| Elche | Alicante | 03203 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| Lucerne | 6004 | Switzerland |
| Zurich | 8063 | Switzerland |
| Changhua | 500 | Taiwan |
| Kaohisung | Taiwan |
| Taichung | 404 | Taiwan |
| Taichung | 407 | Taiwan |
| Taipei | 00112 | Taiwan |
| Taipei | 100 | Taiwan |
| Taipei | 112 | Taiwan |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| Chiang Rai | 57000 | Thailand |
| Hat Yai | 90110 | Thailand |
| Lopburi | 15000 | Thailand |
| Antalya | 07070 | Turkey (Türkiye) |
| Edirne | 22770 | Turkey (Türkiye) |
| Erzurum | 25240 | Turkey (Türkiye) |
| Malatya | 44280 | Turkey (Türkiye) |
| Samsun | 55139 | Turkey (Türkiye) |
| Sıhhiye, Ankara | 06100 | Turkey (Türkiye) |
| Bristol | BS2 8ED | United Kingdom |
| Cardiff | CF14 2TL | United Kingdom |
| London | SW3 6JJ | United Kingdom |
| Manchester | M2O 4BX | United Kingdom |
| Southampton | SO16 6YD | United Kingdom |
| Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| C584058 | onartuzumab |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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