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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel / Carboplatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Until disease progression |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer and Research Center | Chandler | Arizona | 85224 | United States | ||
| Baptist Clinical Research |
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| bavituximab | Drug | Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity. |
|
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| American Institute of Research | Whittier | California | 90603 | United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Community Hospital | Munster | Indiana | 46321 | United States |
| Cedar Valley Medical Specialists, PC | Waterloo | Iowa | 50701 | United States |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| The Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey | 08003 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Presbyterian Hospital | Charlotte | North Carolina | 28204 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| The Christ Hospital Cancer Center Research | Cincinnati | Ohio | 45219 | United States |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | 45042 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Hematology-Oncology of Knoxville/Mercy Medical Center | Knoxville | Tennessee | 37909 | United States |
| Delta Hematology Oncology Associates, PC | Portsmouth | Virginia | 23704 | United States |
| JSC A.Gvamichava National Oncology Center | Tbilisi | Georgia |
| Medulla Chemotherapy and Immunotherapy Clinic | Tbilisi | Georgia |
| BiBi General Hospital & Cancer Centre | Hyderabad | Andhra Pradesh | 500024 | India |
| Mahavir Cancer Sansthan | Patna | Bihar | 801505 | India |
| O.P. Jindal Institute of Cancer & Research | Hisar | Haryana | 125005 | India |
| Bangalore Institute of Oncology Specialty Centre | Bangalore | Karnataka | 560027 | India |
| Kodlikeri Memorial Hospital | Aurangabad | Maharashtra | 431 005 | India |
| Cancer Care Clinic | Nagpur | Maharashtra | 440012 | India |
| Shatabdi Superspecialty Hospital | Nashik | Maharashtra | 422 005 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411 001 | India |
| SMS Medical College Hospital | Jaipur | Rajasthan | 302004 | India |
| State Institution of Healthcare "Pyatigorsk Oncology Dispensary" | Pyatigorsk | Stavropol Territory | 357502 | Russia |
| State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital" | Yaroslavl | Yaroslavl Oblast | 150054 | Russia |
| State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology" | Chelyabinsk | 454087 | Russia |
| State Institution of Healthcare " Ivanovo Regional Oncology Dispensary " | Ivanovo | 153013 | Russia |
| Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN" | Moscow | 115478 | Russia |
| 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 | Russia |
| State Institution of Healthcare "Tula Regional Oncology Dispensary" | Tula | 300053 | Russia |
| City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology; | Dnipropetrovsk | 49102 | Ukraine |
| Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy department #1 | Donetsk | 83092 | Ukraine |
| State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy | Kharkiv | 61024 | Ukraine |
| Kyiv City Oncology Hospital, Thoracal Department | Kyiv | 03115 | Ukraine |
| Uzhgorod Central City Clinical Hospital, City Oncology Center | Uzhhorod | 88000 | Ukraine |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C053518 | CP protocol |
| C547825 | bavituximab |
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