CompletedPhase 2NCT01160601

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

StatusCompleted
PhasePhase 2
U.S. locations40
SponsorPeregrine Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Peregrine Pharmaceuticals
Interventions being studied
Drug: Paclitaxel / Carboplatin; Drug: bavituximab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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