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The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: BIND-014 every 3 weeks | Experimental |
| |
| Arm B: BIND-014 weekly | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIND-014 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with either a complete or partial response | To determine the efficacy of BIND-014 as measured by objective response rate (ORR) in patients with Stage III/IV Non-small cell lung cancer (NSCLC) who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease. | Patients will be followed for the duration of treatment, an expected average of 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experience adverse events | To assess the safety and tolerability of BIND-014 | Patients will be followed for the duration of treatment, an expected average of 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site #10 | Goodyear | Arizona | 85338 | United States | ||
| Investigative Site #04 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22491949 | Background | Hrkach J, Von Hoff D, Mukkaram Ali M, Andrianova E, Auer J, Campbell T, De Witt D, Figa M, Figueiredo M, Horhota A, Low S, McDonnell K, Peeke E, Retnarajan B, Sabnis A, Schnipper E, Song JJ, Song YH, Summa J, Tompsett D, Troiano G, Van Geen Hoven T, Wright J, LoRusso P, Kantoff PW, Bander NH, Sweeney C, Farokhzad OC, Langer R, Zale S. Preclinical development and clinical translation of a PSMA-targeted docetaxel nanoparticle with a differentiated pharmacological profile. Sci Transl Med. 2012 Apr 4;4(128):128ra39. doi: 10.1126/scitranslmed.3003651. |
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| Los Angeles |
| California |
| 90048 |
| United States |
| Investigative Site #02 | Fort Meyers | Florida | 33905 | United States |
| Investigative Site #08 | Newnan | Georgia | 30265 | United States |
| Investigative Site #07 | Zion | Illinois | 60099 | United States |
| Investigative Site #03 | Columbus | Ohio | 43221 | United States |
| Investigative Site #09 | Tulsa | Oklahoma | 74133 | United States |
| Investigative Site #11 | Philadelphia | Pennsylvania | 19124 | United States |
| Investigative Site #05 | Pittsburgh | Pennsylvania | 15232 | United States |
| Investigative Site #01 | Nashville | Tennessee | 37203 | United States |
| Investigative Site #15 | Chelyabinsk | 454087 | Russia |
| Site #17 | Krasnodar | Russia |
| Investigative Site #12 | Moscow | 115478 | Russia |
| Site # 18 | Saint Petersburg | Russia |
| Investigative Site #14 | Saint-Petersberg | 198255 | Russia |
| Investigative Site #13 | Saint-Petersberg | 97758 | Russia |
| Investigative Site #16 | Ufa | 450054 | Russia |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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