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The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with metastatic castration-resistant prostate cancer (mCRPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIND-014 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIND-014 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC | Number of patients with a progression-free survival of 6 months | Patients will be followed for the duration of treatment, an expected average of 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of BIND-014 | Number of patients who experience adverse events | Patients will be followed for the duration of treatment, an expected average of 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site #16 | Los Angeles | California | 90048 | United States | ||
| Investigative Site #14 |
| 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. | |
| 29978216 |
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| San Francisco |
| California |
| 94115 |
| United States |
| Investigative Site #17 | Fort Meyers | Florida | 33908 | United States |
| Investigational Site #12 | Ann Arbor | Michigan | 48109 | United States |
| Investigational Site #11 | New York | New York | 10065 | United States |
| Investigational Site #15 | Chapel Hill | North Carolina | 27514 | United States |
| Investigational Site #13 | Cleveland | Ohio | 44195 | United States |
| Investigational Site #18 | Nashville | Tennessee | 37203 | United States |
| Derived |
| Autio KA, Dreicer R, Anderson J, Garcia JA, Alva A, Hart LL, Milowsky MI, Posadas EM, Ryan CJ, Graf RP, Dittamore R, Schreiber NA, Summa JM, Youssoufian H, Morris MJ, Scher HI. Safety and Efficacy of BIND-014, a Docetaxel Nanoparticle Targeting Prostate-Specific Membrane Antigen for Patients With Metastatic Castration-Resistant Prostate Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1344-1351. doi: 10.1001/jamaoncol.2018.2168. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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