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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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

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



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
Show Show 17 study locations
Sponsors and Collaborators
BIND Therapeutics

Publications:
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Responsible Party: BIND Therapeutics
ClinicalTrials.gov Identifier: NCT01792479    
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:
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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