- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01792479
A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy to Patients With 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 Second-line Therapy to Patients With Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).
Study Overview
Study Type
Interventional
Enrollment (Actual)
64
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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Chelyabinsk, Russian Federation, 454087
- Investigative Site #15
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Krasnodar, Russian Federation
- Site #17
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Moscow, Russian Federation, 115478
- Investigative Site #12
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Saint Petersburg, Russian Federation
- Site # 18
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Saint-Petersberg, Russian Federation, 198255
- Investigative Site #14
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Saint-Petersberg, Russian Federation, 97758
- Investigative Site #13
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Ufa, Russian Federation, 450054
- Investigative Site #16
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Arizona
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Goodyear, Arizona, United States, 85338
- Investigative Site #10
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California
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Los Angeles, California, United States, 90048
- Investigative Site #04
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Florida
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Fort Meyers, Florida, United States, 33905
- Investigative Site #02
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Georgia
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Newnan, Georgia, United States, 30265
- Investigative Site #08
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Illinois
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Zion, Illinois, United States, 60099
- Investigative Site #07
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Ohio
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Columbus, Ohio, United States, 43221
- Investigative Site #03
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Oklahoma
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Tulsa, Oklahoma, United States, 74133
- Investigative Site #09
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19124
- Investigative Site #11
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Pittsburgh, Pennsylvania, United States, 15232
- Investigative Site #05
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Tennessee
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Nashville, Tennessee, United States, 37203
- Investigative Site #01
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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
- 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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A: BIND-014 every 3 weeks
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Experimental: Arm B: BIND-014 weekly
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with either a complete or partial response
Time Frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks
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To determine the efficacy of BIND-014 as measured by objective response rate (ORR) in patients with Stage III/IV Non-small cell lung cancer (NSCLC) who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease.
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Patients will be followed for the duration of treatment, an expected average of 18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who experience adverse events
Time Frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks
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To assess the safety and tolerability of BIND-014
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Patients will be followed for the duration of treatment, an expected average of 18 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2013
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
February 12, 2013
First Submitted That Met QC Criteria
February 13, 2013
First Posted (Estimate)
February 15, 2013
Study Record Updates
Last Update Posted (Estimate)
April 15, 2016
Last Update Submitted That Met QC Criteria
April 14, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIND-014-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Non-small Cell Lung Cancer
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WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
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University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
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National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
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National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
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Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
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Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on BIND-014
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BIND TherapeuticsCompleted
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BIND TherapeuticsCompletedCancer | Metastatic Cancer | Solid TumorsUnited States
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BIND TherapeuticsCompletedSquamous Cell Non-small Cell Lung Cancer | KRAS Positive Patients With Non-small Cell Lung CancerUnited States, Russian Federation
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BIND TherapeuticsTerminatedCervical Cancer | Squamous Cell Carcinoma of Head and Neck | Cholangiocarcinoma | Urothelial CarcinomaRussian Federation, United States
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Huons Co., Ltd.UnknownPost Stroke Upper Limb SpasticityKorea, Republic of
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MedRhythms, Inc.Alexion Pharmaceuticals, Inc.Not yet recruitingNeuromyelitis Optica Spectrum DisorderUnited States
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Huons Co., Ltd.CompletedPost Stroke Upper Limb SpasticityKorea, Republic of
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Fundación Universitaria CIEOUnknownCrowding of Anterior Mandibular TeethColombia
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Flanders Medical Research ProgramCompleted
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C. R. BardCompletedPeripheral Artery DiseaseAustria, Belgium, France, Switzerland, Germany, Italy, Greece, Spain, United Kingdom, Portugal, Saudi Arabia