Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
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-small cell lung cancer (NSCLC).
Checked against the public recordLast updated Apr 19, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Peregrine Pharmaceuticals
- Interventions being studied
- Drug: Paclitaxel / Carboplatin; Drug: bavituximab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * 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 Criteria: * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ironwood Cancer and Research CenterChandler, Arizona
- Baptist Clinical ResearchJonesboro, Arkansas
- American Institute of ResearchWhittier, California
- Baptist Cancer InstituteJacksonville, Florida
- Community HospitalMunster, Indiana
- Cedar Valley Medical Specialists, PCWaterloo, Iowa
- Southeast Nebraska Cancer CenterLincoln, Nebraska
- Dartmouth Hitchcock Medical CenterLebanon, New Hampshire
- The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey
- San Juan Oncology AssociatesFarmington, New Mexico
- Presbyterian HospitalCharlotte, North Carolina
- Gabrail Cancer CenterCanton, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 19, 2017. Always confirm current availability with the study team.