Status:
COMPLETED
Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
Lead Sponsor:
Peregrine Pharmaceuticals
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-...
Eligibility Criteria
Inclusion
- Key
- Adults over 18 years of age with a life expectancy of at least 3 months.
- Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
- Adequate hematologic, renal and hepatic function.
- PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.
- Key
Exclusion
- Squamous cell, small cell, or mixed histology.
- Known history of bleeding diathesis or coagulopathy.
- Cavitary tumors or tumors abutting large blood vessels.
- Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
- Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
- Ongoing therapy with oral or parenteral anticoagulants.
- Concurrent estrogens, anti-estrogens or progesterone compounds.
- Grade 2 or higher peripheral neuropathy.
- Radiotherapy within 2 weeks preceding Study Day 1.
- Symptomatic or clinically active brain metastases.
- Major surgery within 4 weeks of Study Day 1.
- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
- Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01160601
Start Date
June 1 2010
End Date
September 1 2013
Last Update
April 19 2017
Active Locations (40)
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1
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
2
Baptist Clinical Research
Jonesboro, Arkansas, United States, 72401
3
American Institute of Research
Whittier, California, United States, 90603
4
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207