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

Brief Title

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

Official Title

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

Brief 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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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.

Secondary Outcome

 Progression Free Survival

Condition

Urothelial Carcinoma

Intervention

BIND-014 (docetaxel nanoparticles for injectable suspension)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

June 2015

Completion Date

January 2020

Primary Completion Date

October 2016

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Russian Federation

Location Countries

Russian Federation

Administrative Informations

NCT ID

NCT02479178

Organization ID

BIND-014-008

Responsible Party

Sponsor

Study Sponsor

BIND Therapeutics

Study Sponsor

, ,

Verification Date

April 2016