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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)

Primary Purpose

Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIND-014 (docetaxel nanoparticles for injectable suspension)
Sponsored by
BIND Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Investigative Site: #20
  • Investigative Site: #42
  • Investigative Site: #39
  • Investigative Site: #34
  • Investigative Site: #34
  • Investigative Site: #43
  • Investigative Site: # 37
  • Investigative Site: # 33
  • Investigative Site: #74
  • Investigative Site: #75
  • Investigative Site: #70
  • Investigative Site: #80
  • Investigative Site: #81
  • Investigative Site: #84
  • Investigative Site: #85
  • Investigative Site: #73
  • Investigative Site: #78
  • Investigative Site: #79
  • Investigative Site: #88
  • Investigative Site: #77
  • Investigative Site: #72
  • Investigative Site: #87
  • Investigative Site: #82

Outcomes

Primary Outcome Measures

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.
Patients will be followed for ORR for an expected average of 18 weeks

Secondary Outcome Measures

Progression Free Survival
Overall Survival
Best Response
Duration of Response
Time to Response
Disease Control Rate
Safety and Tolerability, as measured by number of participants with adverse events

Full Information

First Posted
June 19, 2015
Last Updated
April 13, 2016
Sponsor
BIND Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02479178
Brief Title
A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
Acronym
iNSITE2
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BIND Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer, Squamous Cell Carcinoma of Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BIND-014 (docetaxel nanoparticles for injectable suspension)
Intervention Description
docetaxel nanoparticles for injectable suspension
Primary Outcome Measure Information:
Title
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.
Description
Patients will be followed for ORR for an expected average of 18 weeks
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
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.
Title
Overall Survival
Time Frame
Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck. Progressive disease after ≥ 1 prior chemotherapy regimen. Patients with brain metastases are eligible if asymptomatic and neurologically stable for at least 4 weeks and are not taking any medications contraindicated Chemotherapy must have been completed at least 4 weeks prior to initiation of study medication ECOG performance status 0-1 Tumors must have measurable disease as per RECIST (version 1.1); Female or male, 18 years of age or older Adequate organ function Life expectancy of > 3 months Exclusion Criteria: Current treatment on another therapeutic clinical trial Prior treatment with docetaxel within 6 months of enrollment Stage II, III or IV cardiac failure Carcinomatous meningitis Ongoing cardiac dysrhythmias Peripheral neuropathy Serious concomitant conditions Pregnant or breast feeding Known sensitivity to ferumoxytol Hypersensitivity to polysorbate 80
Facility Information:
Facility Name
Investigative Site: #20
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Investigative Site: #42
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Investigative Site: #39
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Investigative Site: #34
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Investigative Site: #34
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigative Site: #43
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Investigative Site: # 37
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Investigative Site: # 33
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigative Site: #74
City
Arkhangelsk
Country
Russian Federation
Facility Name
Investigative Site: #75
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Investigative Site: #70
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Investigative Site: #80
City
Murmansk
Country
Russian Federation
Facility Name
Investigative Site: #81
City
Omsk
Country
Russian Federation
Facility Name
Investigative Site: #84
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Investigative Site: #85
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Investigative Site: #73
City
Saint Petersburg
Country
Russian Federation
Facility Name
Investigative Site: #78
City
Saint Petersburg
Country
Russian Federation
Facility Name
Investigative Site: #79
City
Saint Petersburg
Country
Russian Federation
Facility Name
Investigative Site: #88
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Investigative Site: #77
City
Sochi
Country
Russian Federation
Facility Name
Investigative Site: #72
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Investigative Site: #87
City
Ul'yanovsk
Country
Russian Federation
Facility Name
Investigative Site: #82
City
Yaroslavl
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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