A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Study to Determine the Efficacy and Safety of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck

Conditions
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Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer, Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Drug: BIND-014 (docetaxel nanoparticles for injectable suspension)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck. Progressive disease after ≥ 1 prior chemotherapy regimen. Patients with brain metastases are eligible if asymptomatic and neurologically stable for at least 4 weeks and are not taking any medications contraindicated Chemotherapy must have been completed at least 4 weeks prior to initiation of study medication ECOG performance status 0-1 Tumors must have measurable disease as per RECIST (version 1.1); Female or male, 18 years of age or older Adequate organ function Life expectancy of > 3 months Exclusion Criteria: Current treatment on another therapeutic clinical trial Prior treatment with docetaxel within 6 months of enrollment Stage II, III or IV cardiac failure Carcinomatous meningitis Ongoing cardiac dysrhythmias Peripheral neuropathy Serious concomitant conditions Pregnant or breast feeding Known sensitivity to ferumoxytol Hypersensitivity to polysorbate 80

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BIND-014 (docetaxel nanoparticles for injectable suspension)|docetaxel nanoparticles for injectable suspension|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |