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| Name | Class |
|---|---|
| SCRI Development Innovations, LLC | OTHER |
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-FU | Drug | Intravenous repeating dose |
| |
| FOLFOX regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria | up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (complete response + partial response) | up to 4 years | |
| Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death | up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almac Clinical Technologies | San Francisco | California | 94105 | United States | ||
| Rocky Mountain Cancer Centers; Bone and Marrow Trans |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28209746 | Derived | Bendell JC, Hochster H, Hart LL, Firdaus I, Mace JR, McFarlane JJ, Kozloff M, Catenacci D, Hsu JJ, Hack SP, Shames DS, Phan SC, Koeppen H, Cohn AL. A Phase II Randomized Trial (GO27827) of First-Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer. Oncologist. 2017 Mar;22(3):264-271. doi: 10.1634/theoncologist.2016-0223. Epub 2017 Feb 16. |
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| Drug |
Intravenous repeating dose |
|
| Placebo | Drug | Intravenous repeating dose |
|
| bevacizumab [Avastin] | Drug | Intravenous repeating dose |
|
| leucovorin | Drug | Intravenous repeating dose |
|
| onartuzumab [MetMAb] | Drug | Intravenous repeating dose |
|
| Overall survival | up to 4 years |
| Safety: Incidence of adverse events | up to 4 years |
| Denver |
| Colorado |
| 80218 |
| United States |
| Florida Cancer Specialists; SCRI | Fort Myers | Florida | 33901 | United States |
| Florida Hospital Cancer Inst | Orlando | Florida | 32804 | United States |
| Georgia Cancer Specialists - Northside | Atlanta | Georgia | 30341 | United States |
| University of Chicago; Hematology/Oncology | Chicago | Illinois | 60637 | United States |
| Ingalls Cancer Research Center | Harvey | Illinois | 60426 | United States |
| Ingalls Memorial Hospital; Cancer Research Center | Harvey | Illinois | 60426 | United States |
| Baptist Hospital East | Louisville | Kentucky | 40207 | United States |
| Center For Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Saint Louis Cancer Care, LLP | Bridgeton | Missouri | 63044 | United States |
| Research Medical Center - Antibiotic Research Associates, Inc. | Kansas City | Missouri | 64132 | United States |
| Hem-Onc Assoc of Northern NJ | Morristown | New Jersey | 07960 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| Toledo Comm. Onc. Program | Toledo | Ohio | 43623 | United States |
| University of Oklahoma; Stephenson Oklahoma Canc Ctr | Oklahoma City | Oklahoma | 73104 | United States |
| South Carolina Oncology Associates - SCRI | Columbia | South Carolina | 29210 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Onc., PLLC - SCRI | Nashville | Tennessee | 37203 | United States |
| Ctr for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| South Texas Oncology & Hematology, P.A. | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| C410216 | Folfox protocol |
| D000068258 | Bevacizumab |
| D002955 | Leucovorin |
| C584058 | onartuzumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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