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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

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ClinicalTrials.gov Identifier: NCT01792479
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
BIND Therapeutics

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: BIND-014 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: BIND-014 every 3 weeks Drug: BIND-014
Experimental: Arm B: BIND-014 weekly Drug: BIND-014


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Number of patients who experience adverse events [ Time Frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks ]
    To assess the safety and tolerability of BIND-014


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792479


Locations
United States, Arizona
Investigative Site #10
Goodyear, Arizona, United States, 85338
United States, California
Investigative Site #04
Los Angeles, California, United States, 90048
United States, Florida
Investigative Site #02
Fort Meyers, Florida, United States, 33905
United States, Georgia
Investigative Site #08
Newnan, Georgia, United States, 30265
United States, Illinois
Investigative Site #07
Zion, Illinois, United States, 60099
United States, Ohio
Investigative Site #03
Columbus, Ohio, United States, 43221
United States, Oklahoma
Investigative Site #09
Tulsa, Oklahoma, United States, 74133
United States, Pennsylvania
Investigative Site #11
Philadelphia, Pennsylvania, United States, 19124
Investigative Site #05
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Investigative Site #01
Nashville, Tennessee, United States, 37203
Russian Federation
Investigative Site #15
Chelyabinsk, Russian Federation, 454087
Site #17
Krasnodar, Russian Federation
Investigative Site #12
Moscow, Russian Federation, 115478
Site # 18
Saint Petersburg, Russian Federation
Investigative Site #14
Saint-Petersberg, Russian Federation, 198255
Investigative Site #13
Saint-Petersberg, Russian Federation, 97758
Investigative Site #16
Ufa, Russian Federation, 450054
Sponsors and Collaborators
BIND Therapeutics
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: BIND Therapeutics
ClinicalTrials.gov Identifier: NCT01792479     History of Changes
Other Study ID Numbers: BIND-014-005
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by BIND Therapeutics:
NSCLC
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action