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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by BIND Therapeutics
Sponsor:
Information provided by (Responsible Party):
BIND Therapeutics
ClinicalTrials.gov Identifier:
NCT01792479
First received: February 12, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: BIND-014
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by BIND Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Number of patients who experience adverse events [ Time Frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of BIND-014


Estimated Enrollment: 80
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: BIND-014 every 3 weeks Drug: BIND-014
Experimental: Arm B: BIND-014 weekly Drug: BIND-014

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792479

Contacts
Contact: Jason Summa jsumma@bindtherapeutics.com

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

Publications:
Responsible Party: BIND Therapeutics
ClinicalTrials.gov Identifier: NCT01792479     History of Changes
Other Study ID Numbers: BIND-014-005
Study First Received: February 12, 2013
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by BIND Therapeutics:
NSCLC
lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014