Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
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-small-cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 19, 2017 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Peregrine Pharmaceuticals
- Interventions being studied
- Drug: Docetaxel plus bavituximab or placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
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
- South Bay Hematology OncologyCampbell, California
- Medical Oncology Care AssociatesOrange, California
- American Institute of ResearchWhittier, California
- The Center for Hematology-Oncology/Boca Raton Community Hospital, IncBoca Raton, Florida
- Florida Cancer SpecialistsFort Myers, Florida
- Georgia Cancer Specialists, PCAtlanta, Georgia
- Northwest Georgia Oncology Centers, PCMarietta, Georgia
- Rush University Medical CenterChicago, Illinois
- Cedar Valley Medical Specialists, PCWaterloo, Iowa
- Jewish HospitalLouisville, Kentucky
- Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 19, 2017. Always confirm current availability with the study team.