Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Small-Cell Lung Cancer Stage IIIB, Non-Small-Cell Lung Cancer Stage IV, Non-Small-Cell Lung Cancer Metastatic, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01999673

Run by

Peregrine Pharmaceuticals

People needed

582

Starts

2013-12-01

Expected to finish

2017-03-01

Last updated by the study team

2017-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
• 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

Where it is running

• Peregrine Pharmaceuticals Investigational Site — Chandler, Arizona, United States
• Peregrine Pharmaceuticals Investigational Site — Glendale, Arizona, United States
• Peregrine Pharmaceuticals Investigational Site — Greenbrae, California, United States
• Peregrine Pharmaceuticals Investigational Site — Los Angeles, California, United States
• Peregrine Pharmaceuticals Investigational Site — Oceanside, California, United States
• Peregrine Pharmaceuticals Investigational Site — Orange, California, United States
• Peregrine Pharmaceuticals Investigational Site — West Hills, California, United States
• Peregrine Pharmaceuticals Investigational Site — Fort Myers, Florida, United States
• Peregrine Pharmaceuticals Investigational Site — St. Petersburg, Florida, United States
• Peregrine Pharmaceuticals Investigational Site — Tampa, Florida, United States
• Peregrine Pharmaceuticals Investigational Site — Athens, Georgia, United States
• Peregrine Pharmaceuticals Investigational Site — Savannah, Georgia, United States
• Peregrine Pharmaceuticals Investigational Site — Chicago, Illinois, United States
• Peregrine Pharmaceuticals Investigational Site — Indianapolis, Indiana, United States
• Peregrine Pharmaceuticals Investigational Site — Marrero, Louisiana, United States
• Peregrine Pharmaceuticals Investigational Site — Shreveport, Louisiana, United States
• Peregrine Pharmaceuticals Investigational Site — Baltimore, Maryland, United States
• Peregrine Pharmaceuticals Investigational Site — Frederick, Maryland, United States
• Peregrine Pharmaceuticals Investigational Site — Boston, Massachusetts, United States
• Peregrine Pharmaceuticals Investigational Site — Lincoln, Nebraska, United States
• Peregrine Pharmaceuticals Investigational Site — Lebanon, New Hampshire, United States
• Peregrine Pharmaceuticals Investigational Site — Albuquerque, New Mexico, United States
• Peregrine Pharmaceuticals Investigational Site — Winston-Salem, North Carolina, United States
• Peregrine Pharmaceuticals Investigational Site — Cincinnati, Ohio, United States
• Peregrine Pharmaceuticals Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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