A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck (iNSITE2)

BIND Therapeutics

Status and phase: Terminated; Phase 2

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

Treatments: Drug: BIND-014 (docetaxel nanoparticles for injectable suspension)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02479178

BIND-014-008

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)