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

Phase 2TerminatedNCT02479178

BIND Therapeutics73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck. 2. Progressive disease after ≥ 1 prior chemotherapy regimen. 3. Patients with brain metastases are eligible if asymptomatic and neurologically stable for at least 4 weeks and are not taking any medications contraindicated 4. Chemotherapy must have been completed at least 4 weeks prior to initiation of study medication 5. ECOG performance status 0-1 6. Tumors must have measurable disease as per RECIST (version 1.1); 7. Female or male, 18 years of age or older 8. Adequate organ function 9. Life expectancy of \> 3 months Exclusion Criteria: 1. Current treatment on another therapeutic clinical trial 2. Prior treatment with docetaxel within 6 months of enrollment 3. Stage II, III or IV cardiac failure 4. Carcinomatous meningitis 5. Ongoing cardiac dysrhythmias 6. Peripheral neuropathy 7. Serious concomitant conditions 8. Pregnant or breast feeding 9. Known sensitivity to ferumoxytol 10. Hypersensitivity to polysorbate 80

Locations (23)

Investigative Site: #20

Goodyear, Arizona, United States

Investigative Site: #42

Greenbrae, California, United States

Investigative Site: #39

Denver, Colorado, United States

Investigative Site: #34

Detroit, Michigan, United States

Investigative Site: #34

St Louis, Missouri, United States

Investigative Site: #43

Las Vegas, Nevada, United States

Investigative Site: # 37

Oklahoma City, Oklahoma, United States

Investigative Site: # 33

San Antonio, Texas, United States

Investigative Site: #74

Arkhangelsk, Russia

Investigative Site: #75

Kazan', Russia

...and 13 more locations

Outcomes

Primary Outcomes

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

Time frame: 18 weeks

Secondary Outcomes

Progression Free Survival

Time frame: 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

Time frame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation

Best Response

Time frame: 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

Time to Response

Time frame: 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

Safety and Tolerability, as measured by number of participants with adverse events

Time frame: Measured from first dose of study drug until 30 days after study discontinuation