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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000858-57 | 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 mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onartuzumab (MetMAb) with mFOLFOX6 | Experimental | Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin) |
|
| Placebo with mFOLFOX6 | Placebo Comparator | Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) in all patients | Up to 18 months | |
| Progression-free survival (PFS) in patients with Met-positive tumors | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of adverse events | 18 months | |
| Overall survival (OS) | 18 months | |
| Overall response rate (ORR) |
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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 |
|---|---|---|---|---|---|---|
| Denver | Colorado | 80218 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27401892 | Derived | Shah MA, Cho JY, Tan IB, Tebbutt NC, Yen CJ, Kang A, Shames DS, Bu L, Kang YK. A Randomized Phase II Study of FOLFOX With or Without the MET Inhibitor Onartuzumab in Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction. Oncologist. 2016 Sep;21(9):1085-90. doi: 10.1634/theoncologist.2016-0038. Epub 2016 Jul 8. |
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| Onartuzumab (MetMAb) | Drug | Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment |
|
| Oxaliplatin | Drug | Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment |
|
| Folinic acid | Drug | Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment |
|
| Levofolinic acid | Drug | If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment |
|
| 5-Fluorouracil | Drug | 5-Fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment |
|
| 18 months |
| Duration of response (DOR) | 18 months |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Fort Myers | Florida | 33908 | United States |
| St. Petersburg | Florida | 33705 | United States |
| Chicago | Illinois | 60637 | United States |
| Niles | Illinois | 60714 | United States |
| Albany | New York | 12206 | United States |
| New York | New York | 10065 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Nashville | Tennessee | 37203 | United States |
| Austin | Texas | 78731 | United States |
| Bedford | Texas | 76022 | United States |
| Garland | Texas | 77060 | United States |
| The Woodlands | Texas | 77380 | United States |
| Tyler | Texas | 75702 | United States |
| Fairfax | Virginia | 22031 | United States |
| Richmond | Virginia | 23226 | United States |
| Vancouver | Washington | 98684 | United States |
| Sydney | New South Wales | 2139 | Australia |
| Herston | Queensland | 4029 | Australia |
| Woodville South | South Australia | 5011 | Australia |
| East Bentleigh | Victoria | VIC 3165 | Australia |
| Heidelberg | Victoria | 3084 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Singapore | 119228 | Singapore |
| Singapore | 169610 | Singapore |
| Seoul | 05505 | South Korea |
| Seoul | 06351 | South Korea |
| Seoul | 135-720 | South Korea |
| Tainan | 00704 | Taiwan |
| Taipei | 00112 | Taiwan |
| Taipei | 100 | Taiwan |
| Taoyuan County | 333 | Taiwan |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| 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 |
|---|---|
| C584058 | onartuzumab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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