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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small-cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

Until disease progression

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PPHM 0902

NCT ID:

NCT01138163

Start Date:

June 2010

Completion Date:

May 2013

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • NSCLC
  • second-line
  • lung cancer
  • non small cell lung cancer
  • bavituximab
  • monoclonal antibody
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Rush University Medical CenterChicago, Illinois  60612-3824
Florida Cancer SpecialistsFort Myers, Florida  33901
Jewish HospitalLouisville, Kentucky  40202-1886
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Medical Oncology Care AssociatesOrange, California  92668
University of Texas Southwestern Medical CenterDallas, Texas  
Dayton Clinical Oncology ProgramDayton, Ohio  45420
Hanover Medical Specialists, PAWilmington, North Carolina  28401
Cedar Valley Medical Specialists, PCWaterloo, Iowa  50702
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
The Christ Hospital Cancer Center ResearchCincinnati, Ohio  45219
Sarah Cannon Research Institute, LLCNashville, Tennessee  37203
Northwest Georgia Oncology Centers, PCMarietta, Georgia  30060
Pennsylvania State Hershey Cancer InstituteHershey, Pennsylvania  17033
Mary Crowley Cancer Research CentersDallas, Texas  75201
Nebraska Hematology Oncology, PCLincoln, Nebraska  68506
Ironwood Cancer and Research CenterChandler, Arizona  85224
South Bay Hematology OncologyCampbell, California  95008
American Institute of ResearchWhittier, California  90603
The Center for Hematology-Oncology/Boca Raton Community Hospital, IncBoca Raton, Florida  33486
Georgia Cancer Specialists, PCAtlanta, Georgia  30341
Oncology/ Hematology Care, IncCincinnati, Ohio  45236
University of Utah Hospitals and Clinics, Huntsman Cancer InstituteSalt Lake City, Utah  84112