Overview

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

Status:
Terminated

Trial end date:
2020-01-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

BIND Therapeutics

Treatments:

Docetaxel

Criteria

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