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BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree and squamous cell carcinoma of the head and neck.
Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIND-014 (docetaxel nanoparticles for injectable suspension) | Drug | docetaxel nanoparticles for injectable suspension |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the objective response rate (ORR) in patients with advanced urothelial carcinoma (transitional cell carcinoma), cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree and squamous cell carcinoma of the head and neck. | Patients will be followed for ORR for an expected average of 18 weeks | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks. | |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site: #20 | Goodyear | Arizona | 85338 | United States | ||
| Investigative Site: #42 |
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| Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation |
| Best Response | Change in tumor size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks |
| Duration of Response | Change in tumor size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks |
| Time to Response | change in tumor size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug |
| Disease Control Rate | Change in tumor size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks |
| Safety and Tolerability, as measured by number of participants with adverse events | Measured from first dose of study drug until 30 days after study discontinuation |
| Greenbrae |
| California |
| 94904 |
| United States |
| Investigative Site: #39 | Denver | Colorado | 80045 | United States |
| Investigative Site: #34 | Detroit | Michigan | 48201 | United States |
| Investigative Site: #34 | St Louis | Missouri | 63110 | United States |
| Investigative Site: #43 | Las Vegas | Nevada | 89169 | United States |
| Investigative Site: # 37 | Oklahoma City | Oklahoma | 73104 | United States |
| Investigative Site: # 33 | San Antonio | Texas | 78229 | United States |
| Investigative Site: #74 | Arkhangelsk | Russia |
| Investigative Site: #75 | Kazan' | 420029 | Russia |
| Investigative Site: #70 | Moscow | 115478 | Russia |
| Investigative Site: #80 | Murmansk | Russia |
| Investigative Site: #81 | Omsk | Russia |
| Investigative Site: #84 | Saint Petersburg | 198255 | Russia |
| Investigative Site: #85 | Saint Petersburg | 198255 | Russia |
| Investigative Site: #73 | Saint Petersburg | Russia |
| Investigative Site: #78 | Saint Petersburg | Russia |
| Investigative Site: #79 | Saint Petersburg | Russia |
| Investigative Site: #88 | Saratov | 410053 | Russia |
| Investigative Site: #77 | Sochi | Russia |
| Investigative Site: #72 | Ufa | 450054 | Russia |
| Investigative Site: #87 | Ulyanovsk | Russia |
| Investigative Site: #82 | Yaroslavl | Russia |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D018281 | Cholangiocarcinoma |
| D002583 | Uterine Cervical Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
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