Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

Phase 2

Completed

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: Docetaxel plus bavituximab or placebo

• Registration Number: NCT01138163
• Lead Sponsor: Peregrine Pharmaceuticals

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-small-cell lung cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2012-10
• Study Completion: 2013-05
• Status Verified: 2017-04
• Disposition First Submitted: 2017-04-18
• Disposition First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Disposition First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel plus bavituximab 1 mg/kg	Docetaxel plus bavituximab or placebo	-
Docetaxel plus bavituximab 3 mg/kg	Docetaxel plus bavituximab or placebo	-
Docetaxel plus placebo	Docetaxel plus bavituximab or placebo	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	Until disease progression

Trial Locations

Locations (53)

Ironwood Cancer and Research Center; 🇺🇸 Chandler, Arizona, United States

South Bay Hematology Oncology; 🇺🇸 Campbell, California, United States

Medical Oncology Care Associates; 🇺🇸 Orange, California, United States

American Institute of Research; 🇺🇸 Whittier, California, United States

The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc; 🇺🇸 Boca Raton, Florida, United States

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

Georgia Cancer Specialists, PC; 🇺🇸 Atlanta, Georgia, United States

Northwest Georgia Oncology Centers, PC; 🇺🇸 Marietta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Cedar Valley Medical Specialists, PC; 🇺🇸 Waterloo, Iowa, United States

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