Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer
NCT ID: NCT01999673
Last Updated: 2017-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
582 participants
INTERVENTIONAL
2013-12-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
bavituximab
Docetaxel
placebo plus docetaxel
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
Docetaxel
Placebo (for bavituximab)
Interventions
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bavituximab
Docetaxel
Placebo (for bavituximab)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
* Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal and hepatic function
Exclusion Criteria
* Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
* Cavitary tumors or tumors invading or abutting large blood vessels
* Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
* Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
* Grade 2 or higher peripheral neuropathy
18 Years
ALL
No
Sponsors
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Peregrine Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Peregrine Pharmaceuticals Investigational Site
Huntsville, Alabama, United States
Peregrine Pharmaceuticals Investigational Site
Chandler, Arizona, United States
Peregrine Pharmaceuticals Investigational Site
Glendale, Arizona, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Orange, California, United States
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West Hills, California, United States
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Fort Myers, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Athens, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Marrero, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Frederick, Maryland, United States
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Boston, Massachusetts, United States
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Lincoln, Nebraska, United States
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Lebanon, New Hampshire, United States
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Albuquerque, New Mexico, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Middletown, Ohio, United States
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Portland, Oregon, United States
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Hershey, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Temple, Texas, United States
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Seattle, Washington, United States
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Campbelltown, New South Wales, Australia
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Camperdown, New South Wales, Australia
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Tweed Heads, New South Wales, Australia
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Milton, Queensland, Australia
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Redcliffe, Queensland, Australia
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Elizabeth Vale, South Australia, Australia
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Toorak Gardens, South Australia, Australia
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Geelong, Victoria, Australia
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Wodonga, Victoria, Australia
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Antwerp, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Herstal, , Belgium
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Liège, , Belgium
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Mechelen, , Belgium
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Namur, , Belgium
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Marseille, Bouches-du-Rhone, France
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Caen, Calvados, France
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Brest, Finistere, France
Peregrine Pharmaceuticals Investigational Site
Nantes, Loire-Atlantique, France
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Nancy, Meurthe-et-Moselle, France
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Bayonne, Pyrenees-Atlantiques, France
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Rennes, , France
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Saint-Herblain, , France
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Saint-Priest-en-Jarez, , France
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Karlsruhe, Baden-Wurttemberg, Germany
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München, Bavaria, Germany
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Immenhausen, Hesse, Germany
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Marburg, Hesse, Germany
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Cologne, North Rhine-Westphalia, Germany
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Erfurt, Thuringia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Großhansdorf, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Kassel, , Germany
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Mainz, , Germany
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Münster, , Germany
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Villingen-Schwenningen, , Germany
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Pátrai, Achaia, Greece
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Neo Faliro, Athens, Greece
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Athens, Attica, Greece
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Chania, Crete, Greece
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Heraklion, Irakleio, Greece
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Thermi, Thessaloniki, Greece
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Athens, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Gyula, , Hungary
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Szolnok, , Hungary
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Törökbálint, , Hungary
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Zalaegerszeg, , Hungary
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Meldola, Forli-Cesena, Italy
Peregrine Pharmaceuticals Investigational Site
Lido di Camaiore, Lucca, Italy
Peregrine Pharmaceuticals Investigational Site
Taormina, Messina, Italy
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Monza, Monza Brianza, Italy
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Aviano, Pordenone, Italy
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Bergamo, , Italy
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Cremona, , Italy
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Genova, , Italy
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Milan, , Italy
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Turin, , Italy
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Brasov, , Romania
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Ploieşti, , Romania
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Suceava, , Romania
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Turda, , Romania
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Kursk, , Russia
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Nizhny Novgorod, , Russia
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Obninsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Suwon, Gyeonggi-do, South Korea
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Suwon, Gyonggi-do, South Korea
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Busan, , South Korea
Peregrine Pharmaceuticals Investigational Site
Cheongju-si, , South Korea
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Incheon, , South Korea
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Seongnam, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badalona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Manresa, Barcelona, Spain
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Majadahonda, Madrid, Spain
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Pamplona, Navarre, Spain
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Putzu, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
Peregrine Pharmaceuticals Investigational Site
Tainan City, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
Peregrine Pharmaceuticals Investigational Site
Taipei, , Taiwan
Peregrine Pharmaceuticals Investigational Site
Taipei, , Taiwan
Peregrine Pharmaceuticals Investigational Site
Taoyuan District, , Taiwan
Peregrine Pharmaceuticals Investigational Site
Chernivtsi, , Ukraine
Peregrine Pharmaceuticals Investigational Site
Dnipropetrovsk, , Ukraine
Peregrine Pharmaceuticals Investigational Site
Khmelnytskyi, , Ukraine
Peregrine Pharmaceuticals Investigational Site
Kyiv, , Ukraine
Peregrine Pharmaceuticals Investigational Site
Lutsk, , Ukraine
Peregrine Pharmaceuticals Investigational Site
Uzhhorod, , Ukraine
Countries
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References
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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.
Other Identifiers
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2013-003953-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PPHM 1202
Identifier Type: -
Identifier Source: org_study_id
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