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

Status

Completed

Conditions

Intervention / Treatment

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

  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Investigative Site #15
      • Krasnodar, Russian Federation
        • Site #17
      • Moscow, Russian Federation, 115478
        • Investigative Site #12
      • Saint Petersburg, Russian Federation
        • Site # 18
      • Saint-Petersberg, Russian Federation, 198255
        • Investigative Site #14
      • Saint-Petersberg, Russian Federation, 97758
        • Investigative Site #13
      • Ufa, Russian Federation, 450054
        • Investigative Site #16
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Investigative Site #10
    • California
      • Los Angeles, California, United States, 90048
        • Investigative Site #04
    • Florida
      • Fort Meyers, Florida, United States, 33905
        • Investigative Site #02
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Investigative Site #08
    • Illinois
      • Zion, Illinois, United States, 60099
        • Investigative Site #07
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Investigative Site #03
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Investigative Site #09
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19124
        • Investigative Site #11
      • Pittsburgh, Pennsylvania, United States, 15232
        • Investigative Site #05
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Investigative Site #01

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

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
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.
Patients will be followed for the duration of treatment, an expected average of 18 weeks

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
To assess the safety and tolerability of BIND-014
Patients will be followed for the duration of treatment, an expected average of 18 weeks

Collaborators and Investigators

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

Sponsor

BIND Therapeutics

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.

General Publications

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.

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