Non-small-cell Lung Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
Verified date | April 2017 |
Source | Peregrine Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | May 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults over age 18 years of age with a life expectancy of at least 3 months. - Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen. - Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter. - Eastern Cooperative Oncology Group (ECOG) Performance Status = 2. - Adequate hematologic, renal, and hepatic function. - PT/INR = 1.5 × ULN; aPTT time = 1.5 × ULN. - New York Heart Association classification I or II Exclusion Criteria: - Squamous, small cell, or mixed histology. - Known history of bleeding diathesis or coagulopathy. - Cavitary tumors or tumors invading or abutting large blood vessels. - Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening. - Venous thromboembolic events within 6 months of screening. - Ongoing therapy with oral or parenteral anticoagulants. - Concurrent estrogens, anti-estrogens or progesterone compounds. - Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1. - Symptomatic or clinically active brain metastases. - Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening. - Grade 2 or higher peripheral neuropathy |
Country | Name | City | State |
---|---|---|---|
Georgia | JSC A.Gvamichava National Oncology Center | Tbilisi | |
Georgia | Medulla Chemotherapy and Immunotherapy Clinic | Tbilisi | |
India | Kodlikeri Memorial Hospital | Aurangabad | Maharashtra |
India | Bangalore Institute of Oncology Specialty Centre | Bangalore | Karnataka |
India | Kidwai Memorial Institute of Oncology | Bangalore | Karnataka |
India | All India Institute of Medical Sciences | Delhi | |
India | Shanti Mukund Hospital Curie Cancer Center | Delhi | |
India | O.P. Jindal Institute of Cancer & Research | Hisar | Haryana |
India | BiBi General Hospital & Cancer Centre | Hyderabad | Andhra Pradesh |
India | Nizam's Institute of Medical Sciences | Hyderabad | Andra Pradesh |
India | SMS Medical College Hospital | Jaipur | Rajasthan |
India | Chhatrapati Shahuji Maharaj Medical University | Lucknow | Uttar Pradesh |
India | Bharath Hospital and Institute of Oncology | Mysore | Karnataka |
India | Cancer Care Clinic | Nagpur | Maharashtra |
India | Shatabdi Superspecialty Hospital | Nashik | Maharashtra |
India | Mahavir Cancer Sansthan | Patna | Bihar |
India | Ruby Hall Clinic | Pune | Maharashtra |
Russian Federation | State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology" | Chelyabinsk | |
Russian Federation | State Institution of Healthcare " Ivanovo Regional Oncology Dispensary " | Ivanovo | |
Russian Federation | Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN" | Moscow | |
Russian Federation | State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University named after academician I.P. Pavlov of Federal Agency of Healthcare and Social Development" | Saint Petersburg | |
Russian Federation | State Institution of Healthcare "Pyatigorsk Oncology Dispensary" | Stavropol' | |
Russian Federation | State Institution of Healthcare "Tula Regional Oncology Dispensary" | Tula | |
Russian Federation | State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital" | Yaroslavl | |
Ukraine | City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology; | Dnipropetrovsk | |
Ukraine | Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy | Donetsk | |
Ukraine | State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy | Kharkiv | |
Ukraine | Kyiv City Oncology Hospital, Thoracal Department | Kyiv | |
Ukraine | Uzhgorod Central City Clinical Hospital, City Oncology Center | Uzhgorod | |
United States | Georgia Cancer Specialists, PC | Atlanta | Georgia |
United States | The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc | Boca Raton | Florida |
United States | South Bay Hematology Oncology | Campbell | California |
United States | Ironwood Cancer and Research Center | Chandler | Arizona |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Oncology/ Hematology Care, Inc | Cincinnati | Ohio |
United States | The Christ Hospital Cancer Center Research | Cincinnati | Ohio |
United States | South Carolina Oncology Associates | Columbia | South Carolina |
United States | Coastal Bend Cancer Center | Corpus Christi | Texas |
United States | Mary Crowley Cancer Research Centers | Dallas | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Dayton Clinical Oncology Program | Dayton | Ohio |
United States | Florida Cancer Specialists | Fort Myers | Florida |
United States | Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick | Maryland |
United States | Pennsylvania State Hershey Cancer Institute | Hershey | Pennsylvania |
United States | Nebraska Hematology Oncology, PC | Lincoln | Nebraska |
United States | Jewish Hospital | Louisville | Kentucky |
United States | Northwest Georgia Oncology Centers, PC | Marietta | Georgia |
United States | Sarah Cannon Research Institute, LLC | Nashville | Tennessee |
United States | Medical Oncology Care Associates | Orange | California |
United States | University of Utah Hospitals and Clinics, Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Cedar Valley Medical Specialists, PC | Waterloo | Iowa |
United States | American Institute of Research | Whittier | California |
United States | Hanover Medical Specialists, PA | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Peregrine Pharmaceuticals |
United States, Georgia, India, Russian Federation, Ukraine,
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---|---|---|---|---|
Primary | Objective Response Rate | Until disease progression |
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