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

Primary Purpose

Non-small-cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Docetaxel plus bavituximab or placebo
Sponsored by
Peregrine Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring NSCLC, second-line, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ironwood Cancer and Research Center
  • South Bay Hematology Oncology
  • Medical Oncology Care Associates
  • American Institute of Research
  • The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc
  • Florida Cancer Specialists
  • Georgia Cancer Specialists, PC
  • Northwest Georgia Oncology Centers, PC
  • Rush University Medical Center
  • Cedar Valley Medical Specialists, PC
  • Jewish Hospital
  • Frederick Memorial Hospital Regional Cancer Therapy Center
  • Nebraska Hematology Oncology, PC
  • Hanover Medical Specialists, PA
  • The Christ Hospital Cancer Center Research
  • Oncology/ Hematology Care, Inc
  • Dayton Clinical Oncology Program
  • Pennsylvania State Hershey Cancer Institute
  • South Carolina Oncology Associates
  • Sarah Cannon Research Institute, LLC
  • Coastal Bend Cancer Center
  • Mary Crowley Cancer Research Centers
  • University of Texas Southwestern Medical Center
  • University of Utah Hospitals and Clinics, Huntsman Cancer Institute
  • JSC A.Gvamichava National Oncology Center
  • Medulla Chemotherapy and Immunotherapy Clinic
  • BiBi General Hospital & Cancer Centre
  • Nizam's Institute of Medical Sciences
  • Mahavir Cancer Sansthan
  • O.P. Jindal Institute of Cancer & Research
  • Bangalore Institute of Oncology Specialty Centre
  • Kidwai Memorial Institute of Oncology
  • Bharath Hospital and Institute of Oncology
  • Kodlikeri Memorial Hospital
  • Cancer Care Clinic
  • Shatabdi Superspecialty Hospital
  • Ruby Hall Clinic
  • SMS Medical College Hospital
  • Chhatrapati Shahuji Maharaj Medical University
  • Shanti Mukund Hospital Curie Cancer Center
  • All India Institute of Medical Sciences
  • State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
  • State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
  • Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
  • 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"
  • State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
  • State Institution of Healthcare "Tula Regional Oncology Dispensary"
  • State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
  • City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
  • Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy
  • State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
  • Kyiv City Oncology Hospital, Thoracal Department
  • Uzhgorod Central City Clinical Hospital, City Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Docetaxel plus bavituximab 1 mg/kg

Docetaxel plus bavituximab 3 mg/kg

Docetaxel plus placebo

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate

Secondary Outcome Measures

Full Information

First Posted
June 3, 2010
Last Updated
April 18, 2017
Sponsor
Peregrine Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01138163
Brief Title
Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peregrine Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
NSCLC, second-line, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel plus bavituximab 1 mg/kg
Arm Type
Experimental
Arm Title
Docetaxel plus bavituximab 3 mg/kg
Arm Type
Experimental
Arm Title
Docetaxel plus placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Docetaxel plus bavituximab or placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
Until disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ironwood Cancer and Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
South Bay Hematology Oncology
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Medical Oncology Care Associates
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Georgia Cancer Specialists, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Cedar Valley Medical Specialists, PC
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50701
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Frederick Memorial Hospital Regional Cancer Therapy Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
Nebraska Hematology Oncology, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Hanover Medical Specialists, PA
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
The Christ Hospital Cancer Center Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Oncology/ Hematology Care, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Dayton Clinical Oncology Program
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Pennsylvania State Hershey Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Sarah Cannon Research Institute, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Coastal Bend Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Mary Crowley Cancer Research Centers
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Utah Hospitals and Clinics, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
JSC A.Gvamichava National Oncology Center
City
Tbilisi
Country
Georgia
Facility Name
Medulla Chemotherapy and Immunotherapy Clinic
City
Tbilisi
Country
Georgia
Facility Name
BiBi General Hospital & Cancer Centre
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500024
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
State/Province
Andra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Mahavir Cancer Sansthan
City
Patna
State/Province
Bihar
ZIP/Postal Code
801505
Country
India
Facility Name
O.P. Jindal Institute of Cancer & Research
City
Hisar
State/Province
Haryana
ZIP/Postal Code
125005
Country
India
Facility Name
Bangalore Institute of Oncology Specialty Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 027
Country
India
Facility Name
Kidwai Memorial Institute of Oncology
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560029
Country
India
Facility Name
Bharath Hospital and Institute of Oncology
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570017
Country
India
Facility Name
Kodlikeri Memorial Hospital
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431 005
Country
India
Facility Name
Cancer Care Clinic
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Shatabdi Superspecialty Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 005
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
SMS Medical College Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302 004
Country
India
Facility Name
Chhatrapati Shahuji Maharaj Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Shanti Mukund Hospital Curie Cancer Center
City
Delhi
ZIP/Postal Code
110 0902
Country
India
Facility Name
All India Institute of Medical Sciences
City
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
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"
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
City
Stavropol'
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
State Institution of Healthcare "Tula Regional Oncology Dispensary"
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Kyiv City Oncology Hospital, Thoracal Department
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Uzhgorod Central City Clinical Hospital, City Oncology Center
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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