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

April 13, 2016 updated by: BIND Therapeutics

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Investigative Site: #74
      • Kazan, Russian Federation, 420029
        • Investigative Site: #75
      • Moscow, Russian Federation, 115478
        • Investigative Site: #70
      • Murmansk, Russian Federation
        • Investigative Site: #80
      • Omsk, Russian Federation
        • Investigative Site: #81
      • Saint Petersburg, Russian Federation, 198255
        • Investigative Site: #84
      • Saint Petersburg, Russian Federation, 198255
        • Investigative Site: #85
      • Saint Petersburg, Russian Federation
        • Investigative Site: #73
      • Saint Petersburg, Russian Federation
        • Investigative Site: #78
      • Saint Petersburg, Russian Federation
        • Investigative Site: #79
      • Saratov, Russian Federation, 410053
        • Investigative Site: #88
      • Sochi, Russian Federation
        • Investigative Site: #77
      • Ufa, Russian Federation, 450054
        • Investigative Site: #72
      • Ul'yanovsk, Russian Federation
        • Investigative Site: #87
      • Yaroslavl, Russian Federation
        • Investigative Site: #82
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Investigative Site: #20
    • California
      • Greenbrae, California, United States, 94904
        • Investigative Site: #42
    • Colorado
      • Denver, Colorado, United States, 80045
        • Investigative Site: #39
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Investigative Site: #34
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Investigative Site: #34
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Investigative Site: #43
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Investigative Site: # 37
    • Texas
      • San Antonio, Texas, United States, 78229
        • Investigative Site: # 33

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 18 weeks
Patients will be followed for ORR for an expected average of 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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
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
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 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
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
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
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
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
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
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
Measured from first dose of study drug until 30 days after study discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BIND Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIND-014-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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