Urothelial CarcinomaPhase 2iNSITE2NCT02479178
A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing BIND-014 (docetaxel nanoparticles for injectable suspension) in people with Urothelial Carcinoma and Cholangiocarcinoma, run by BIND Therapeutics at 23 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer
- What is being tested?
- BIND-014 (docetaxel nanoparticles for injectable suspension)
- Type of treatment
- Injection or infusion
- How many people
- 73 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jun 2015to Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- Female or male, 18 years of age or older
- Adequate organ function
- Life expectancy of > 3 months
Who cannot join
- 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
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- Serious concomitant conditions
- Pregnant or breast feeding
- Known sensitivity to ferumoxytol
- Hypersensitivity to polysorbate 80
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
Russia15 sites
Investigative Site: #74
Arkhangelsk
Investigative Site: #75
Kazan', 420029
Investigative Site: #70
Moscow, 115478
Investigative Site: #80
Murmansk
Investigative Site: #81
Omsk
Investigative Site: #84
Saint Petersburg, 198255
Investigative Site: #85
Saint Petersburg, 198255
Investigative Site: #73
Saint Petersburg
Investigative Site: #78
Saint Petersburg
Investigative Site: #79
Saint Petersburg
Investigative Site: #88
Saratov, 410053
Investigative Site: #77
Sochi
Investigative Site: #72
Ufa, 450054
Investigative Site: #87
Ulyanovsk
Investigative Site: #82
Yaroslavl
United States8 sites
Investigative Site: #39
Denver, Colorado, 80045
Investigative Site: #34
Detroit, Michigan, 48201
Investigative Site: #20
Goodyear, Arizona, 85338
Investigative Site: #42
Greenbrae, California, 94904
Investigative Site: #43
Las Vegas, Nevada, 89169
Investigative Site: # 37
Oklahoma City, Oklahoma, 73104
Investigative Site: # 33
San Antonio, Texas, 78229
Investigative Site: #34
St Louis, Missouri, 63110
About this study
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
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.
- Conditions
- Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer, Squamous Cell Carcinoma of Head and Neck
- Being tested
- BIND-014 (docetaxel nanoparticles for injectable suspension)
- Medical subject headings
- Carcinoma, Transitional Cell, Cholangiocarcinoma, Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIND-014 (docetaxel nanoparticles for injectable suspension)Drug
docetaxel nanoparticles for injectable suspension
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 weeks
Secondary outcomes (7)
Progression Free Survival
Measured: 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
Measured: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Best Response
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Measured from first dose of study drug until 30 days after study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- BIND Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479178
- Sponsor's protocol ID
- BIND-014-008
- Acronym
- iNSITE2
- Status last verified
- Apr 2016
- First submitted
- 19 Jun 2015
- Last updated
- 14 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02479178
- Acronym / sponsor ID
- iNSITE2 / BIND-014-008
- Conditions
- Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer, Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 73 participants (actual)
- Lead sponsor
- BIND TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIND-014 (docetaxel nanoparticles for injectable suspension)docetaxel nanoparticles for injectable suspension | Drug | – |
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.
Time frame: 18 weeks
Patients will be followed for ORR for an expected average of 18 weeks
7 secondary outcomes
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.
Overall Survival
Time frame: 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
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
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
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIND-014 (docetaxel nanoparticles for injectable suspension) in people with Urothelial Carcinoma and Cholangiocarcinoma, run by BIND Therapeutics at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Russia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.