Status:
COMPLETED
Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
Lead Sponsor:
Peregrine Pharmaceuticals
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01138163
Start Date
June 1 2010
End Date
May 1 2013
Last Update
April 19 2017
Active Locations (53)
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1
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
2
South Bay Hematology Oncology
Campbell, California, United States, 95008
3
Medical Oncology Care Associates
Orange, California, United States, 92868
4
American Institute of Research
Whittier, California, United States, 90603