Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01160601
Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
A Phase 2 study testing Paclitaxel / Carboplatin and bavituximab in people with Non-Squamous Non-Small Cell Lung Cancer, run by Peregrine Pharmaceuticals at 40 sites in 5 countries.
Trial summary
This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- Paclitaxel / Carboplatin and bavituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 40 sitesin 5 countries
- Study dates
- Jun 2010to Sep 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 18 years of age with a life expectancy of at least 3 months.
- Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
- Adequate hematologic, renal and hepatic function.
- PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.
Who cannot join
- Squamous cell, small cell, or mixed histology.
- Known history of bleeding diathesis or coagulopathy.
- Cavitary tumors or tumors abutting large blood vessels.
- Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
- Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
- Ongoing therapy with oral or parenteral anticoagulants.
Show all 13Show fewer
- Concurrent estrogens, anti-estrogens or progesterone compounds.
- Grade 2 or higher peripheral neuropathy.
- Radiotherapy within 2 weeks preceding Study Day 1.
- Symptomatic or clinically active brain metastases.
- Major surgery within 4 weeks of Study Day 1.
- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
- Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
Trial locations and contacts
40 sites in 5 countries.
40 sites in 5 countries
United States17 sites
Gabrail Cancer Center
Canton, Ohio, 44718
Ironwood Cancer and Research Center
Chandler, Arizona, 85224
Presbyterian Hospital
Charlotte, North Carolina, 28204
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, 45219
San Juan Oncology Associates
Farmington, New Mexico, 87401
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Baptist Cancer Institute
Jacksonville, Florida, 32207
Baptist Clinical Research
Jonesboro, Arkansas, 72401
Hematology-Oncology of Knoxville/Mercy Medical Center
Knoxville, Tennessee, 37909
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042
Community Hospital
Munster, Indiana, 46321
Delta Hematology Oncology Associates, PC
Portsmouth, Virginia, 23704
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, 50701
American Institute of Research
Whittier, California, 90603
India9 sites
Bangalore Institute of Oncology Specialty Centre
Bangalore, Karnataka, 560027
Kodlikeri Memorial Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431 005
O.P. Jindal Institute of Cancer & Research
Hisar, Haryana, 125005
BiBi General Hospital & Cancer Centre
Hyderabad, Andhra Pradesh, 500024
SMS Medical College Hospital
Jaipur, Rajasthan, 302004
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 Institution of Healthcare "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Territory, 357502
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 "Tula Regional Oncology Dispensary"
Tula, 300053
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, Yaroslavl Oblast, 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 department #1
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, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- Paclitaxel / Carboplatin, bavituximab
- Keywords
- NSCLC, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel / CarboplatinDrug
Patients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
bavituximabDrug
Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel/carboplatin plus bavituximab | Experimental | Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly. Receives: Drug: Paclitaxel / Carboplatin; Drug: bavituximab |
| paclitaxel/carboplatin | Active comparator | Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles. Receives: Drug: Paclitaxel / Carboplatin |
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 posted12 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous 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
- None (open label)
- Enrolment
- 86 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
- NCT01160601
- Sponsor's protocol ID
- PPHM 1001
- Status last verified
- Apr 2017
- First submitted
- 8 Jul 2010
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01160601
- Acronym / sponsor ID
- PPHM 1001
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Keywords
- NSCLC, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Jul 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.
This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paclitaxel/carboplatin plus bavituximab | Experimental | Drug: Paclitaxel / Carboplatin, Drug: bavituximabPatients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly. |
| paclitaxel/carboplatin | Active comparator | Drug: Paclitaxel / CarboplatinPatients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults over 18 years of age with a life expectancy of at least 3 months.
- Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
- Adequate hematologic, renal and hepatic function.
- PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.
Key exclusion criteria (13 listed)
- Squamous cell, small cell, or mixed histology.
- Known history of bleeding diathesis or coagulopathy.
- Cavitary tumors or tumors abutting large blood vessels.
- Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
- Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) 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 |
|---|---|---|
| Paclitaxel / CarboplatinPatients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles. | Drug | paclitaxel/carboplatin, paclitaxel/carboplatin plus bavituximab |
| bavituximabPatients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity. | Drug | paclitaxel/carboplatin plus bavituximab |
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.
40 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel / Carboplatin and bavituximab in people with Non-Squamous Non-Small Cell Lung Cancer, run by Peregrine Pharmaceuticals at 40 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 5 inclusion and 13 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 40 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. 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.