Clinical trial NCT02479178: A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urothelial Carcinoma
Cholangiocarcinoma
Cervical Cancer
Squamous Cell Carcinoma of Head and Neck
Lead sponsor: BIND Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 18 weeks
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 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.
measure: Overall Survival
timeFrame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
measure: Best Response
timeFrame: 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
measure: Duration of Response
timeFrame: 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
measure: Time to Response
timeFrame: 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
measure: Disease Control Rate
timeFrame: 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
measure: Safety and Tolerability, as measured by number of participants with adverse events
timeFrame: Measured from first dose of study drug until 30 days after study discontinuation
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Investigative Site: #20
state: Arizona
city: Greenbrae
country: United States
facility: Investigative Site: #42
state: California
city: Denver
country: United States
facility: Investigative Site: #39
state: Colorado
city: Detroit
country: United States
facility: Investigative Site: #34
state: Michigan
city: St. Louis
country: United States
facility: Investigative Site: #34
state: Missouri
city: Las Vegas
country: United States
facility: Investigative Site: #43
state: Nevada
city: Oklahoma City
country: United States
facility: Investigative Site: # 37
state: Oklahoma
city: San Antonio
country: United States
facility: Investigative Site: # 33
state: Texas
city: Arkhangelsk
country: Russian Federation
facility: Investigative Site: #74
city: Kazan
country: Russian Federation
facility: Investigative Site: #75
city: Moscow
country: Russian Federation
facility: Investigative Site: #70
city: Murmansk
country: Russian Federation
facility: Investigative Site: #80
city: Omsk
country: Russian Federation
facility: Investigative Site: #81
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #84
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #85
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #73
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #78
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #79
city: Saratov
country: Russian Federation
facility: Investigative Site: #88
city: Sochi
country: Russian Federation
facility: Investigative Site: #77
city: Ufa
country: Russian Federation
facility: Investigative Site: #72
city: Ul'yanovsk
country: Russian Federation
facility: Investigative Site: #87
city: Yaroslavl
country: Russian Federation
facility: Investigative Site: #82
Study officials:
References: