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

  • Russian Federation
      • Archangelsk, Russian Federation, 163045
        • Investigative Site: #74
      • Kazan, Russian Federation, 420029
        • Investigative Site: #78
      • Moscow, Russian Federation, 115478
        • Investigative Site: #70
      • Rostov-on-Don, Russian Federation, 603024
        • Investigative Site: #79
      • Saint Petersburg, Russian Federation, 197022
        • Investigative Site: #76
      • Saint Petersburg, Russian Federation, 197758
        • Investigative Site: #71
      • Saint Petersburg, Russian Federation, 197758
        • Investigative Site: #73
      • Saint Petersburg, Russian Federation, 198255
        • Investigative Site: #77
    • Bashkortastan
      • Ufa, Bashkortastan, Russian Federation, 450054
        • Investigative Site: #72
    • Moscow Region
      • Istra settle., Moscow Region, Russian Federation, 143423
        • Investigative Site: #75
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Investigative Site: #51
      • Goodyear, Arizona, United States, 85338
        • Investigative Site: #30
      • Phoenix, Arizona, United States, 85016
        • Investigative Site: #44
      • Sedona, Arizona, United States, 86336
        • Investigative Site: #41
    • California
      • Duarte, California, United States, 91010
        • Investigative Site: #58
      • La Jolla, California, United States, 92093
        • Investigative Site: #47
      • Los Angeles, California, United States, 90048
        • Investigative Site: #32
      • San Francisco, California, United States, 94115
        • Investigative Site: #50
    • Florida
      • Fort Meyers, Florida, United States, 33916
        • Investigative Site: #46
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Investigative Site: #53
      • Savannah, Georgia, United States, 31405
        • Investigative Site: #56
    • Illinois
      • Zion, Illinois, United States, 60099
        • Investigative Site: #35
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Investigative Site: #36
    • Oregon
      • Portland, Oregon, United States, 97239
        • Investigative Site: #60
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15232
        • Investigative Site: #34
      • Pittsburgh, Pennsylvania, United States, 15240
        • Investigative Site: # 59
    • Texas
      • Amarillo, Texas, United States, 79106
        • Investigative Site: #39
      • Dallas, Texas, United States, 75231
        • Investigative Site: #42
      • Dallas, Texas, United States, 75237
        • Investigative Site: 38
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Investigative Site: #40
    • Washington
      • Vancouver, Washington, United States, 98684
        • Investigative Site: #45
      • Yakima, Washington, United States, 98902
        • Investigative Site: #37

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
Experimental: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

What is the study measuring?

Primary 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
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

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
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
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.
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.
Overall survival
Time Frame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
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
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
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
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
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.
Measured from first dose of study drug until 30 days after study discontinuation.
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,
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,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BIND Therapeutics

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

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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