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

April 18, 2017 updated by: Peregrine Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia
        • JSC A.Gvamichava National Oncology Center
      • Tbilisi, Georgia
        • Medulla Chemotherapy and Immunotherapy Clinic
  • India
      • Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Delhi, India, 110 0902
        • Shanti Mukund Hospital Curie Cancer Center
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500024
        • BiBi General Hospital & Cancer Centre
    • Andra Pradesh
      • Hyderabad, Andra Pradesh, India, 500082
        • Nizam's Institute of Medical Sciences
    • Bihar
      • Patna, Bihar, India, 801505
        • Mahavir Cancer Sansthan
    • Haryana
      • Hisar, Haryana, India, 125005
        • O.P. Jindal Institute of Cancer & Research
    • Karnataka
      • Bangalore, Karnataka, India, 560029
        • Kidwai Memorial Institute of Oncology
      • Bangalore, Karnataka, India, 560 027
        • Bangalore Institute of Oncology Specialty Centre
      • Mysore, Karnataka, India, 570017
        • Bharath Hospital and Institute of Oncology
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431 005
        • Kodlikeri Memorial Hospital
      • Nagpur, Maharashtra, India, 440012
        • Cancer Care Clinic
      • Nashik, Maharashtra, India, 422 005
        • Shatabdi Superspecialty Hospital
      • Pune, Maharashtra, India, 411 001
        • Ruby Hall Clinic
    • Rajasthan
      • Jaipur, Rajasthan, India, 302 004
        • SMS Medical College Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Chhatrapati Shahuji Maharaj Medical University
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
      • Ivanovo, Russian Federation, 153013
        • State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
      • Moscow, Russian Federation, 115478
        • Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
      • Saint Petersburg, Russian Federation, 197022
        • State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University named after academician I.P. Pavlov of Federal Agency of Healthcare and Social Development"
      • Stavropol', Russian Federation, 357502
        • State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
      • Tula, Russian Federation, 300053
        • State Institution of Healthcare "Tula Regional Oncology Dispensary"
      • Yaroslavl, Russian Federation, 150054
        • State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
      • Donetsk, Ukraine, 83092
        • Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy
      • Kharkiv, Ukraine, 61024
        • State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
      • Kyiv, Ukraine, 03115
        • Kyiv City Oncology Hospital, Thoracal Department
      • Uzhgorod, Ukraine, 88000
        • Uzhgorod Central City Clinical Hospital, City Oncology Center
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer and Research Center
    • California
      • Campbell, California, United States, 95008
        • South Bay Hematology Oncology
      • Orange, California, United States, 92868
        • Medical Oncology Care Associates
      • Whittier, California, United States, 90603
        • American Institute of Research
    • Florida
      • Boca Raton, Florida, United States, 33486
        • The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists, PC
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Iowa
      • Waterloo, Iowa, United States, 50701
        • Cedar Valley Medical Specialists, PC
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
    • Maryland
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital Regional Cancer Therapy Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology Oncology, PC
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Hanover Medical Specialists, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital Cancer Center Research
      • Cincinnati, Ohio, United States, 45236
        • Oncology/ Hematology Care, Inc
      • Dayton, Ohio, United States, 45429
        • Dayton Clinical Oncology Program
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Pennsylvania State Hershey Cancer Institute
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute, LLC
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Coastal Bend Cancer Center
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75201
        • Mary Crowley Cancer Research Centers
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Hospitals and Clinics, Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel plus bavituximab 1 mg/kg
Drug: Docetaxel plus bavituximab or placebo
Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Experimental: Docetaxel plus bavituximab 3 mg/kg
Drug: Docetaxel plus bavituximab or placebo
Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Placebo Comparator: Docetaxel plus placebo
Drug: Docetaxel plus bavituximab or placebo
Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: Until disease progression
Until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peregrine Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPHM 0902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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