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

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ClinicalTrials.gov Identifier: NCT02479178
Recruitment Status : Terminated
First Posted : June 24, 2015
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
BIND Therapeutics

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.


Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Cholangiocarcinoma Cervical Cancer Squamous Cell Carcinoma of Head and Neck Drug: BIND-014 (docetaxel nanoparticles for injectable suspension) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : January 2020



Intervention Details:
  • Drug: BIND-014 (docetaxel nanoparticles for injectable suspension)
    docetaxel nanoparticles for injectable suspension


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. ]
  2. Overall Survival [ Time Frame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479178


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

Responsible Party: BIND Therapeutics
ClinicalTrials.gov Identifier: NCT02479178     History of Changes
Other Study ID Numbers: BIND-014-008
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Cholangiocarcinoma
Head and Neck Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Adenocarcinoma
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action