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

Cervical Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02479178
• Other study ID #: BIND-014-008
• Status: Terminated
• Phase: Phase 2
• First received: June 19, 2015
• Last updated: April 13, 2016
• Start date: June 2015
• Est. completion date: January 2020

Study information

• Verified date: April 2016
• Source: BIND Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationRussia: Ethics Committee
• Study type: Interventional

Clinical 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.

Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: January 2020
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Carcinoma, Transitional Cell
• Cervical Cancer
• Cholangiocarcinoma
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Urothelial Carcinoma
• Uterine Cervical Neoplasms

Intervention

Drug:
• BIND-014 (docetaxel nanoparticles for injectable suspension)
docetaxel nanoparticles for injectable suspension

Locations

Country	Name	City	State
Russian Federation	Investigative Site: #74	Arkhangelsk
Russian Federation	Investigative Site: #75	Kazan
Russian Federation	Investigative Site: #70	Moscow
Russian Federation	Investigative Site: #80	Murmansk
Russian Federation	Investigative Site: #81	Omsk
Russian Federation	Investigative Site: #73	Saint Petersburg
Russian Federation	Investigative Site: #78	Saint Petersburg
Russian Federation	Investigative Site: #79	Saint Petersburg
Russian Federation	Investigative Site: #84	Saint Petersburg
Russian Federation	Investigative Site: #85	Saint Petersburg
Russian Federation	Investigative Site: #88	Saratov
Russian Federation	Investigative Site: #77	Sochi
Russian Federation	Investigative Site: #72	Ufa
Russian Federation	Investigative Site: #87	Ul'yanovsk
Russian Federation	Investigative Site: #82	Yaroslavl
United States	Investigative Site: #39	Denver	Colorado
United States	Investigative Site: #34	Detroit	Michigan
United States	Investigative Site: #20	Goodyear	Arizona
United States	Investigative Site: #42	Greenbrae	California
United States	Investigative Site: #43	Las Vegas	Nevada
United States	Investigative Site: # 37	Oklahoma City	Oklahoma
United States	Investigative Site: # 33	San Antonio	Texas
United States	Investigative Site: #34	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
BIND Therapeutics

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	Overall Survival		Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes