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

Stopped early · Phase 2

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

In brief

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.

Key facts

Study ID

NCT02479178

Run by

BIND Therapeutics

People needed

73

Starts

2015-06-01

Expected to finish

2020-01-01

Last updated by the study team

2016-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Investigative Site: #70 — Moscow, Russia
• Investigative Site: #80 — Murmansk, Russia
• Investigative Site: #81 — Omsk, Russia
• Investigative Site: #84 — Saint Petersburg, Russia
• Investigative Site: #85 — Saint Petersburg, Russia
• Investigative Site: #73 — Saint Petersburg, Russia
• Investigative Site: #78 — Saint Petersburg, Russia
• Investigative Site: #79 — Saint Petersburg, Russia
• Investigative Site: #88 — Saratov, Russia
• Investigative Site: #77 — Sochi, Russia
• Investigative Site: #72 — Ufa, Russia
• Investigative Site: #87 — Ulyanovsk, Russia
• Investigative Site: #82 — Yaroslavl, Russia

Full record on ClinicalTrials.gov

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