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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005547-27 | EudraCT Number |
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This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFIRI + Cetuximab | Active Comparator |
| |
| FOLFIRI + MEHD7945A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-fluorouracil | Drug | Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter [mg/m^2] administered as intravenous bolus and then 5-FU 2400 mg/m^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) According to Modified RECIST v1.1 Criteria | approximately 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of 5-Fluorouracil | Pre-dose, 1 hour and after end of infusion on Day 1 Cycles 1-4 | |
| Plasma Concentration of Irinotecan | Pre-dose, 1 hour and after end of infusion on Day 1 Cycles 1-4 |
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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 |
|---|---|---|---|---|---|---|
| Bakersfield | California | 93309 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29506988 | Derived | Hill AG, Findlay MP, Burge ME, Jackson C, Alfonso PG, Samuel L, Ganju V, Karthaus M, Amatu A, Jeffery M, Bartolomeo MD, Bridgewater J, Coveler AL, Hidalgo M, Kapp AV, Sufan RI, McCall BB, Hanley WD, Penuel EM, Pirzkall A, Tabernero J. Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer. Clin Cancer Res. 2018 May 15;24(10):2276-2284. doi: 10.1158/1078-0432.CCR-17-0646. Epub 2018 Mar 5. |
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|
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| Cetuximab | Drug | Cetuximab 400 mg/m^2 intravenous infusion as a loading dose on Day 1 Cycle 1, followed by 250 mg/m^2 intravenous infusion weekly until documented disease progression or unacceptable toxicity. |
|
|
| Irinotecan | Drug | Standard Irinotecan chemotherapy (180 milligram per square meter [mg/m^2] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. |
|
|
| Leucovorin | Drug | Standard Leucovorin chemotherapy (400 mg/m^2 [racemic form] or 200 mg/m^2 [L-isomer form] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity. |
|
|
| MEHD7945A | Drug | MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity. |
|
| Number of Participants With Anti-MEHD7945A Antibodies | Pre-dose on Day 1 Cycles 1, 4, and 8; treatment completion visit (up to approximately 2 years) |
| Number of Participants With Objective Response According to Modified RECIST v1.1 Criteria | approximately 2 year |
| Duration of Objective Response According to Modified RECIST v1.1 Criteria | approximately 2 year |
| Overall Survival (OS) | approximately 2 year |
| Number of Participants With Adverse Events | approximately 2 year |
| Maximum Observed Serum Concentration (Cmax) of MEHD7945A | Pre-dose and 30 minutes after end of infusion on Day 1 Cycles 1-4, Cycle 8 and at treatment completion (up to approximately 2 year) |
| Minimum Observed Serum Concentration (Cmin) of MEHD7945A | Pre-dose on Day 1 Cycles 1-4, Cycle 8 and at treatment completion (up to approximately 2 year) |
| Fullerton |
| California |
| 92835 |
| United States |
| Los Angeles | California | 90033 | United States |
| Los Angeles | California | 90095 | United States |
| San Luis Obispo | California | 93454 | United States |
| Santa Barbara | California | 93105 | United States |
| Aurora | Colorado | 80045 | United States |
| Orange Park | Florida | 32073 | United States |
| Harvey | Illinois | 60426 | United States |
| Paducah | Kentucky | 42003 | United States |
| Rockville | Maryland | 20850 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02215 | United States |
| Detroit | Michigan | 48201 | United States |
| Jefferson City | Missouri | 65109 | United States |
| Las Vegas | Nevada | 89148 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Kirkland | Washington | 98034 | United States |
| Seattle | Washington | 98109 | United States |
| Darlinghurst | New South Wales | 2010 | Australia |
| New Lambton Heights | New South Wales | 2305 | Australia |
| St Leonards | New South Wales | 2065 | Australia |
| Sydney | New South Wales | 2217 | Australia |
| Waratah | New South Wales | 2298 | Australia |
| Wollongong | New South Wales | 2500 | Australia |
| Herston | Queensland | 4029 | Australia |
| Southport | Queensland | 4215 | Australia |
| Adelaide | South Australia | 5041 | Australia |
| Frankston | Victoria | 3199 | Australia |
| Brussels | 1200 | Belgium |
| Charleroi | B6000 | Belgium |
| Haine-Saint-Paul | 7100 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Créteil | 94000 | France |
| Lyon | 69373 | France |
| Paris | 75015 | France |
| Villejuif | 94805 | France |
| Dresden | 01307 | Germany |
| München | 81737 | Germany |
| München | 81925 | Germany |
| Stuttgart | 70199 | Germany |
| Trier | 54290 | Germany |
| Milan | Lombardy | 20133 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Orbassano | Piedmont | 10043 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Padova | Veneto | 35128 | Italy |
| Auckland | 1142 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Dunedin | 9001 | New Zealand |
| Tauranga | 3112 | New Zealand |
| Brasov | 500091 | Romania |
| Bucharest | 022328 | Romania |
| Bucharest | 030171 | Romania |
| Iași | 700106 | Romania |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28050 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Aberdeen | AB25 2ZN | United Kingdom |
| London | NW1 2BU | United Kingdom |
| Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Oxford | OX3 7LJ | United Kingdom |
| 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 |
| D000068818 | Cetuximab |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| C569960 | MEHD7945A |
| 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| 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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