- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02283320
A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer
April 14, 2016 updated by: BIND Therapeutics
An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Archangelsk, Russian Federation, 163045
- Investigative Site: #74
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Kazan, Russian Federation, 420029
- Investigative Site: #78
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Moscow, Russian Federation, 115478
- Investigative Site: #70
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Rostov-on-Don, Russian Federation, 603024
- Investigative Site: #79
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Saint Petersburg, Russian Federation, 197022
- Investigative Site: #76
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Saint Petersburg, Russian Federation, 197758
- Investigative Site: #71
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Saint Petersburg, Russian Federation, 197758
- Investigative Site: #73
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Saint Petersburg, Russian Federation, 198255
- Investigative Site: #77
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Bashkortastan
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Ufa, Bashkortastan, Russian Federation, 450054
- Investigative Site: #72
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Moscow Region
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Istra settle., Moscow Region, Russian Federation, 143423
- Investigative Site: #75
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Arizona
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Chandler, Arizona, United States, 85224
- Investigative Site: #51
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Goodyear, Arizona, United States, 85338
- Investigative Site: #30
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Phoenix, Arizona, United States, 85016
- Investigative Site: #44
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Sedona, Arizona, United States, 86336
- Investigative Site: #41
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California
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Duarte, California, United States, 91010
- Investigative Site: #58
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La Jolla, California, United States, 92093
- Investigative Site: #47
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Los Angeles, California, United States, 90048
- Investigative Site: #32
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San Francisco, California, United States, 94115
- Investigative Site: #50
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Florida
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Fort Meyers, Florida, United States, 33916
- Investigative Site: #46
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Georgia
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Newnan, Georgia, United States, 30265
- Investigative Site: #53
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Savannah, Georgia, United States, 31405
- Investigative Site: #56
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Illinois
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Zion, Illinois, United States, 60099
- Investigative Site: #35
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Nevada
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Las Vegas, Nevada, United States, 89119
- Investigative Site: #36
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Oregon
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Portland, Oregon, United States, 97239
- Investigative Site: #60
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Pennsylvania
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Pittsburg, Pennsylvania, United States, 15232
- Investigative Site: #34
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Pittsburgh, Pennsylvania, United States, 15240
- Investigative Site: # 59
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Texas
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Amarillo, Texas, United States, 79106
- Investigative Site: #39
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Dallas, Texas, United States, 75231
- Investigative Site: #42
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Dallas, Texas, United States, 75237
- Investigative Site: 38
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Virginia
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Blacksburg, Virginia, United States, 24060
- Investigative Site: #40
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Washington
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Vancouver, Washington, United States, 98684
- Investigative Site: #45
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Yakima, Washington, United States, 98902
- Investigative Site: #37
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females at least 18 years of age
- Diagnosis of NSCLC with locally advanced or metastatic disease
- Positive for KRAS mutation or Squamous cell histology
- Previously treated with one platinum-based chemotherapy
- Disease status must be that of measurable and/or evaluable disease
- Performance status of 0 to 1 on the ECOG Scale
- Prior chemotherapy completed at least 3 weeks prior to study enrollment
- Prior radiation therapy allowed to < 25% of the bone marrow
- Patient compliance and geographic proximity that allow adequate follow-up
- Adequate organ function
- Patients with reproductive potential must use contraceptive methods
- Signed informed consent from patient
Exclusion Criteria:
- Active infection
- Pregnancy or planning to become pregnant
- Breast feeding
- Serious concomitant systemic disorders
- Second primary malignancy
- Patients who are symptomatic from brain metastasis
- Presence of detectable (by physical exam) third-space fluid collections
- More than 1 prior cytotoxic chemotherapy regimen for advanced disease
- Prior treatment with docetaxel
- History of severe hypersensitivity reaction to polysorbate 80
- Peripheral neuropathy at study entry
- Patients known to be HIV positive
- Patients known to be seropositive for hepatitis C hepatitis B
- Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Disease control rate
Time Frame: Change in tumour 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
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Change in tumour 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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease control rate
Time Frame: Change in tumour 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
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Change in tumour 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
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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.
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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.
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Overall survival
Time Frame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
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Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
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Duration of response
Time Frame: Change in tumour 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
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Change in tumour 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
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Time to response
Time Frame: change in tumour 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
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change in tumour 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
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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.
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Measured from first dose of study drug until 30 days after study discontinuation.
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Objective response rate
Time Frame: change in tumour 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 12 weeks,
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change in tumour 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 12 weeks,
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
October 21, 2014
First Submitted That Met QC Criteria
November 4, 2014
First Posted (Estimate)
November 5, 2014
Study Record Updates
Last Update Posted (Estimate)
April 18, 2016
Last Update Submitted That Met QC Criteria
April 14, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- BIND-014-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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