A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
iNSITE2
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
1 other identifier
interventional
73
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2015
Typical duration for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedApril 14, 2016
April 1, 2016
1.3 years
June 19, 2015
April 13, 2016
Conditions
Outcome Measures
Primary Outcomes (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.
Patients will be followed for ORR for an expected average of 18 weeks
18 weeks
Secondary Outcomes (7)
Progression Free Survival
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
Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Best Response
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
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
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
- +2 more secondary outcomes
Interventions
docetaxel nanoparticles for injectable suspension
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Investigative Site: #20
Goodyear, Arizona, 85338, United States
Investigative Site: #42
Greenbrae, California, 94904, United States
Investigative Site: #39
Denver, Colorado, 80045, United States
Investigative Site: #34
Detroit, Michigan, 48201, United States
Investigative Site: #34
St Louis, Missouri, 63110, United States
Investigative Site: #43
Las Vegas, Nevada, 89169, United States
Investigative Site: # 37
Oklahoma City, Oklahoma, 73104, United States
Investigative Site: # 33
San Antonio, Texas, 78229, United States
Investigative Site: #74
Arkhangelsk, Russia
Investigative Site: #75
Kazan', 420029, Russia
Investigative Site: #70
Moscow, 115478, Russia
Investigative Site: #80
Murmansk, Russia
Investigative Site: #81
Omsk, Russia
Investigative Site: #84
Saint Petersburg, 198255, Russia
Investigative Site: #85
Saint Petersburg, 198255, Russia
Investigative Site: #73
Saint Petersburg, Russia
Investigative Site: #78
Saint Petersburg, Russia
Investigative Site: #79
Saint Petersburg, Russia
Investigative Site: #88
Saratov, 410053, Russia
Investigative Site: #77
Sochi, Russia
Investigative Site: #72
Ufa, 450054, Russia
Investigative Site: #87
Ulyanovsk, Russia
Investigative Site: #82
Yaroslavl, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2015
First Posted
June 24, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2016
Study Completion
January 1, 2020
Last Updated
April 14, 2016
Record last verified: 2016-04