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

Phase 2

Terminated

• Conditions: Cholangiocarcinoma; Urothelial Carcinoma; Cervical Cancer; Squamous Cell Carcinoma of Head and Neck

• Registration Number: NCT02479178
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14
• Primary Completion: 2016-10
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Disease Control Rate	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 from first dose of study drug until 30 days after study discontinuation

Trial Locations

Locations (22)

Investigative Site: #79; 🇷🇺 Saint Petersburg, Russian Federation

Investigative Site: #70; 🇷🇺 Moscow, Russian Federation

Investigative Site: #75; 🇷🇺 Kazan, Russian Federation

Investigative Site: #78; 🇷🇺 Saint Petersburg, Russian Federation

Investigative Site: #20; 🇺🇸 Goodyear, Arizona, United States

Investigative Site: #43; 🇺🇸 Las Vegas, Nevada, United States

Investigative Site: #42; 🇺🇸 Greenbrae, California, United States

Investigative Site: # 37; 🇺🇸 Oklahoma City, Oklahoma, United States

Investigative Site: #39; 🇺🇸 Denver, Colorado, United States

Investigative Site: #34; 🇺🇸 St. Louis, Missouri, United States

Investigative Site: #80; 🇷🇺 Murmansk, Russian Federation

Investigative Site: #81; 🇷🇺 Omsk, Russian Federation

Investigative Site: # 33; 🇺🇸 San Antonio, Texas, United States

Investigative Site: #74; 🇷🇺 Arkhangelsk, Russian Federation

Investigative Site: #88; 🇷🇺 Saratov, Russian Federation

Investigative Site: #77; 🇷🇺 Sochi, Russian Federation

Investigative Site: #84; 🇷🇺 Saint Petersburg, Russian Federation

Investigative Site: #85; 🇷🇺 Saint Petersburg, Russian Federation

Investigative Site: #73; 🇷🇺 Saint Petersburg, Russian Federation

Investigative Site: #72; 🇷🇺 Ufa, Russian Federation

Investigative Site: #87; 🇷🇺 Ul'yanovsk, Russian Federation

Investigative Site: #82; 🇷🇺 Yaroslavl, Russian Federation