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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003953-13 | EudraCT Number |
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The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bavituximab plus docetaxel | Experimental | Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression. |
|
| placebo plus docetaxel | Placebo Comparator | Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bavituximab | Biological |
| ||
| Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Approximately up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Approximately up to 36 months | |
| Overall Response Rate | Approximately up to 36 months | |
| Safety |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peregrine Pharmaceuticals Investigational Site | Huntsville | Alabama | 35805 | United States | ||
| Peregrine Pharmaceuticals Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29767677 | Derived | Gerber DE, Horn L, Boyer M, Sanborn R, Natale R, Palmero R, Bidoli P, Bondarenko I, Germonpre P, Ghizdavescu D, Kotsakis A, Lena H, Losonczy G, Park K, Su WC, Tang M, Lai J, Kallinteris NL, Shan JS, Reck M, Spigel DR. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer. Ann Oncol. 2018 Jul 1;29(7):1548-1553. doi: 10.1093/annonc/mdy177. |
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|
|
| Placebo (for bavituximab) | Other |
|
As measured by adverse event rates and laboratory evaluations |
| Approximately up to 36 months |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Peregrine Pharmaceuticals Investigational Site | Glendale | Arizona | 85306 | United States |
| Peregrine Pharmaceuticals Investigational Site | Greenbrae | California | 94904 | United States |
| Peregrine Pharmaceuticals Investigational Site | Los Angeles | California | 90048 | United States |
| Peregrine Pharmaceuticals Investigational Site | Oceanside | California | 92056 | United States |
| Peregrine Pharmaceuticals Investigational Site | Orange | California | 92868 | United States |
| Peregrine Pharmaceuticals Investigational Site | West Hills | California | 91307 | United States |
| Peregrine Pharmaceuticals Investigational Site | Fort Myers | Florida | 33916 | United States |
| Peregrine Pharmaceuticals Investigational Site | St. Petersburg | Florida | 33705 | United States |
| Peregrine Pharmaceuticals Investigational Site | Tampa | Florida | 33612 | United States |
| Peregrine Pharmaceuticals Investigational Site | Athens | Georgia | 30607 | United States |
| Peregrine Pharmaceuticals Investigational Site | Savannah | Georgia | 31404 | United States |
| Peregrine Pharmaceuticals Investigational Site | Chicago | Illinois | 60637 | United States |
| Peregrine Pharmaceuticals Investigational Site | Indianapolis | Indiana | 46254 | United States |
| Peregrine Pharmaceuticals Investigational Site | Marrero | Louisiana | 70006 | United States |
| Peregrine Pharmaceuticals Investigational Site | Shreveport | Louisiana | 71101 | United States |
| Peregrine Pharmaceuticals Investigational Site | Baltimore | Maryland | 21201 | United States |
| Peregrine Pharmaceuticals Investigational Site | Frederick | Maryland | 21701 | United States |
| Peregrine Pharmaceuticals Investigational Site | Boston | Massachusetts | 02114 | United States |
| Peregrine Pharmaceuticals Investigational Site | Lincoln | Nebraska | 68506 | United States |
| Peregrine Pharmaceuticals Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| Peregrine Pharmaceuticals Investigational Site | Albuquerque | New Mexico | 87131 | United States |
| Peregrine Pharmaceuticals Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Peregrine Pharmaceuticals Investigational Site | Cincinnati | Ohio | 45242 | United States |
| Peregrine Pharmaceuticals Investigational Site | Middletown | Ohio | 45042 | United States |
| Peregrine Pharmaceuticals Investigational Site | Portland | Oregon | 97213 | United States |
| Peregrine Pharmaceuticals Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Peregrine Pharmaceuticals Investigational Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Peregrine Pharmaceuticals Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Peregrine Pharmaceuticals Investigational Site | Knoxville | Tennessee | 37909 | United States |
| Peregrine Pharmaceuticals Investigational Site | Nashville | Tennessee | 37203 | United States |
| Peregrine Pharmaceuticals Investigational Site | Nashville | Tennessee | 37323 | United States |
| Peregrine Pharmaceuticals Investigational Site | Abilene | Texas | 79606 | United States |
| Peregrine Pharmaceuticals Investigational Site | Dallas | Texas | 75201 | United States |
| Peregrine Pharmaceuticals Investigational Site | Dallas | Texas | 75390 | United States |
| Peregrine Pharmaceuticals Investigational Site | Fort Worth | Texas | 76104 | United States |
| Peregrine Pharmaceuticals Investigational Site | Temple | Texas | 76508 | United States |
| Peregrine Pharmaceuticals Investigational Site | Seattle | Washington | 98108 | United States |
| Peregrine Pharmaceuticals Investigational Site | Campbelltown | New South Wales | 2560 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Tweed Heads | New South Wales | 2485 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Milton | Queensland | 4064 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Redcliffe | Queensland | 4020 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Elizabeth Vale | South Australia | 5112 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Toorak Gardens | South Australia | 5065 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Geelong | Victoria | 3220 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Wodonga | Victoria | 3690 | Australia |
| Peregrine Pharmaceuticals Investigational Site | Antwerp | 2020 | Belgium |
| Peregrine Pharmaceuticals Investigational Site | Brussels | 1000 | Belgium |
| Peregrine Pharmaceuticals Investigational Site | Ghent | 9000 | Belgium |
| Peregrine Pharmaceuticals Investigational Site | Herstal | 4040 | Belgium |
| Peregrine Pharmaceuticals Investigational Site | Liège | 4000 | Belgium |
| Peregrine Pharmaceuticals Investigational Site | Mechelen | 2800 | Belgium |
| Peregrine Pharmaceuticals Investigational Site | Namur | 5000 | Belgium |
| Peregrine Pharmaceuticals Investigational Site | Marseille | Bouches-du-Rhone | 13273 | France |
| Peregrine Pharmaceuticals Investigational Site | Caen | Calvados | 14076 | France |
| Peregrine Pharmaceuticals Investigational Site | Brest | Finistere | 29609 | France |
| Peregrine Pharmaceuticals Investigational Site | Nantes | Loire-Atlantique | 44202 | France |
| Peregrine Pharmaceuticals Investigational Site | Nancy | Meurthe-et-Moselle | 54100 | France |
| Peregrine Pharmaceuticals Investigational Site | Bayonne | Pyrenees-Atlantiques | 64100 | France |
| Peregrine Pharmaceuticals Investigational Site | Rennes | 35033 | France |
| Peregrine Pharmaceuticals Investigational Site | Saint-Herblain | 44805 | France |
| Peregrine Pharmaceuticals Investigational Site | Saint-Priest-en-Jarez | 42271 | France |
| Peregrine Pharmaceuticals Investigational Site | Karlsruhe | Baden-Wurttemberg | 76137 | Germany |
| Peregrine Pharmaceuticals Investigational Site | München | Bavaria | 81675 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Immenhausen | Hesse | 34376 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Marburg | Hesse | 35043 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Cologne | North Rhine-Westphalia | 51109 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Erfurt | Thuringia | 99089 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Berlin | 12200 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Berlin | 13125 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Großhansdorf | 22927 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Halle | 06120 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Hamburg | 21075 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Kassel | 34125 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Mainz | 55131 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Münster | 48149 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Villingen-Schwenningen | 78052 | Germany |
| Peregrine Pharmaceuticals Investigational Site | Pátrai | Achaia | 26500 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Neo Faliro | Athens | 18547 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Athens | Attica | 12464 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Chania | Crete | 73300 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Heraklion | Irakleio | 71110 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Thermi | Thessaloniki | 57001 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Athens | 11527 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Larissa | 41110 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Thessaloniki | 56429 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Thessaloniki | 57010 | Greece |
| Peregrine Pharmaceuticals Investigational Site | Budapest | 1121 | Hungary |
| Peregrine Pharmaceuticals Investigational Site | Budapest | 1125 | Hungary |
| Peregrine Pharmaceuticals Investigational Site | Győr | 9023 | Hungary |
| Peregrine Pharmaceuticals Investigational Site | Gyula | 5703 | Hungary |
| Peregrine Pharmaceuticals Investigational Site | Szolnok | 5004 | Hungary |
| Peregrine Pharmaceuticals Investigational Site | Törökbálint | 2045 | Hungary |
| Peregrine Pharmaceuticals Investigational Site | Zalaegerszeg | 8900 | Hungary |
| Peregrine Pharmaceuticals Investigational Site | Meldola | Forli-Cesena | 47014 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Lido di Camaiore | Lucca | 55041 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Taormina | Messina | 98039 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Monza | Monza Brianza | 20900 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Aviano | Pordenone | 33081 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Bergamo | 24127 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Cremona | 26100 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Genova | 16132 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Milan | 20162 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Turin | 10126 | Italy |
| Peregrine Pharmaceuticals Investigational Site | Brasov | 500091 | Romania |
| Peregrine Pharmaceuticals Investigational Site | Cluj-Napoca | 400058 | Romania |
| Peregrine Pharmaceuticals Investigational Site | Cluj-Napoca | 400349 | Romania |
| Peregrine Pharmaceuticals Investigational Site | Ploieşti | 100337 | Romania |
| Peregrine Pharmaceuticals Investigational Site | Suceava | 720237 | Romania |
| Peregrine Pharmaceuticals Investigational Site | Turda | 401103 | Romania |
| Peregrine Pharmaceuticals Investigational Site | Kursk | 305035 | Russia |
| Peregrine Pharmaceuticals Investigational Site | Nizhny Novgorod | 603081 | Russia |
| Peregrine Pharmaceuticals Investigational Site | Obninsk | 249036 | Russia |
| Peregrine Pharmaceuticals Investigational Site | Saint Petersburg | 194291 | Russia |
| Peregrine Pharmaceuticals Investigational Site | Saint Petersburg | 197022 | Russia |
| Peregrine Pharmaceuticals Investigational Site | Saint Petersburg | 197758 | Russia |
| Peregrine Pharmaceuticals Investigational Site | Yaroslavl | 150054 | Russia |
| Peregrine Pharmaceuticals Investigational Site | Yekaterinburg | 620036 | Russia |
| Peregrine Pharmaceuticals Investigational Site | Suwon | Gyeonggi-do | 443-380 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Suwon | Gyonggi-do | 442-723 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Busan | 602-702 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Cheongju-si | 361711 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Incheon | 400-711 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Seongnam | 463-707 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Seoul | 135-710 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Seoul | 137-701 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Seoul | 156707 | South Korea |
| Peregrine Pharmaceuticals Investigational Site | Badalona | Barcelona | 08916 | Spain |
| Peregrine Pharmaceuticals Investigational Site | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Manresa | Barcelona | 08243 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Majadahonda | Madrid | 28222 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Pamplona | Navarre | 31008 | Spain |
| Peregrine Pharmaceuticals Investigational Site | A Coruña | 15006 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Barcelona | 08003 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Barcelona | 08035 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Barcelona | 08041 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Madrid | 28007 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Madrid | 28040 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Madrid | 28041 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Madrid | 28050 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Málaga | 29010 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Valencia | 46017 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Valencia | 46026 | Spain |
| Peregrine Pharmaceuticals Investigational Site | Kaohsiung City | 833 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Putzu | 613 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Taichung | 402 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Taichung | 40705 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Tainan | 704 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Tainan | 736 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Taipei | 100 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Taipei | 10449 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Taipei | 112 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Taoyuan | 333 | Taiwan |
| Peregrine Pharmaceuticals Investigational Site | Chernivtsi | 58013 | Ukraine |
| Peregrine Pharmaceuticals Investigational Site | Dnipropetrovsk | 49102 | Ukraine |
| Peregrine Pharmaceuticals Investigational Site | Khmelnytskyi | 29009 | Ukraine |
| Peregrine Pharmaceuticals Investigational Site | Kyiv | 03115 | Ukraine |
| Peregrine Pharmaceuticals Investigational Site | Lutsk | 43018 | Ukraine |
| Peregrine Pharmaceuticals Investigational Site | Uzhhorod | 88000 | Ukraine |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C547825 | bavituximab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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