Non-small-cell Lung CancerPhase 2NCT01138163
Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
A Phase 2 study of Non-small-cell Lung Cancer, run by Peregrine Pharmaceuticals at 53 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 53 sitesin 5 countries
- Study dates
- Jun 2010to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
53 sites in 5 countries.
53 sites in 5 countries
United States24 sites
Georgia Cancer Specialists, PC
Atlanta, Georgia, 30341
The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc
Boca Raton, Florida, 33486
South Bay Hematology Oncology
Campbell, California, 95008
Ironwood Cancer and Research Center
Chandler, Arizona, 85224
Rush University Medical Center
Chicago, Illinois, 60612
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, 45219
Oncology/ Hematology Care, Inc
Cincinnati, Ohio, 45236
South Carolina Oncology Associates
Columbia, South Carolina, 29210
Coastal Bend Cancer Center
Corpus Christi, Texas, 78404
Mary Crowley Cancer Research Centers
Dallas, Texas, 75201
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Dayton Clinical Oncology Program
Dayton, Ohio, 45429
Florida Cancer Specialists
Fort Myers, Florida, 33916
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, 21701
Pennsylvania State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
Nebraska Hematology Oncology, PC
Lincoln, Nebraska, 68506
Jewish Hospital
Louisville, Kentucky, 40202
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, 37203
Medical Oncology Care Associates
Orange, California, 92868
University of Utah Hospitals and Clinics, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, 50701
American Institute of Research
Whittier, California, 90603
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401
India15 sites
Bangalore Institute of Oncology Specialty Centre
Bangalore, Karnataka, 560 027
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, 560029
Kodlikeri Memorial Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431 005
Shanti Mukund Hospital Curie Cancer Center
Delhi, 110 0902
All India Institute of Medical Sciences
Delhi, 110029
O.P. Jindal Institute of Cancer & Research
Hisar, Haryana, 125005
BiBi General Hospital & Cancer Centre
Hyderabad, Andhra Pradesh, 500024
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500082
SMS Medical College Hospital
Jaipur, Rajasthan, 302 004
Chhatrapati Shahuji Maharaj Medical University
Lucknow, Uttar Pradesh, 226003
Bharath Hospital and Institute of Oncology
Mysore, Karnataka, 570017
Cancer Care Clinic
Nagpur, Maharashtra, 440012
Shatabdi Superspecialty Hospital
Nashik, Maharashtra, 422 005
Mahavir Cancer Sansthan
Patna, Bihar, 801505
Ruby Hall Clinic
Pune, Maharashtra, 411 001
Russia7 sites
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
Chelyabinsk, 454087
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
Ivanovo, 153013
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
Moscow, 115478
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"
Saint Petersburg, 197022
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
Stavropol, 357502
State Institution of Healthcare "Tula Regional Oncology Dispensary"
Tula, 300053
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, 150054
Ukraine5 sites
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
Dnipropetrovsk, 49102
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy
Donetsk, 83092
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
Kharkiv, 61024
Kyiv City Oncology Hospital, Thoracal Department
Kyiv, 03115
Uzhgorod Central City Clinical Hospital, City Oncology Center
Uzhhorod, 88000
Georgia2 sites
JSC A.Gvamichava National Oncology Center
Tbilisi
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi
About this study
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
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.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- Docetaxel plus bavituximab or placebo
- Keywords
- NSCLC, second-line, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel plus bavituximab or placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel plus bavituximab 1 mg/kg | Experimental | Not described Receives: Drug: Docetaxel plus bavituximab or placebo |
| Docetaxel plus bavituximab 3 mg/kg | Experimental | Not described Receives: Drug: Docetaxel plus bavituximab or placebo |
| Docetaxel plus placebo | Placebo comparator | Not described Receives: Drug: Docetaxel plus bavituximab or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: Until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138163
- Sponsor's protocol ID
- PPHM 0902
- Status last verified
- Apr 2017
- First submitted
- 3 Jun 2010
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01138163
- Acronym / sponsor ID
- PPHM 0902
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- NSCLC, second-line, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Docetaxel plus bavituximab 1 mg/kg | Experimental | Drug: Docetaxel plus bavituximab or placebo |
| Docetaxel plus bavituximab 3 mg/kg | Experimental | Drug: Docetaxel plus bavituximab or placebo |
| Docetaxel plus placebo | Placebo comparator | Drug: Docetaxel plus bavituximab or placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel plus bavituximab or placeboPatients 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. | Drug | Docetaxel plus bavituximab 1 mg/kg, Docetaxel plus bavituximab 3 mg/kg, Docetaxel plus placebo |
Primary outcome
Objective Response Rate
Time frame: Until disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Non-small-cell Lung Cancer, run by Peregrine Pharmaceuticals at 53 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, India, Russia, Ukraine, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Until disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.