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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01792479
First Posted: February 15, 2013
Last Update Posted: April 15, 2016
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.
Information provided by (Responsible Party):
BIND Therapeutics
February 12, 2013
February 15, 2013
April 15, 2016
April 2013
April 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01792479 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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
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).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
Drug: BIND-014
  • Experimental: Arm A: BIND-014 every 3 weeks
    Intervention: Drug: BIND-014
  • Experimental: Arm B: BIND-014 weekly
    Intervention: Drug: BIND-014
Hrkach J, Von Hoff D, Mukkaram Ali M, Andrianova E, Auer J, Campbell T, De Witt D, Figa M, Figueiredo M, Horhota A, Low S, McDonnell K, Peeke E, Retnarajan B, Sabnis A, Schnipper E, Song JJ, Song YH, Summa J, Tompsett D, Troiano G, Van Geen Hoven T, Wright J, LoRusso P, Kantoff PW, Bander NH, Sweeney C, Farokhzad OC, Langer R, Zale S. Preclinical development and clinical translation of a PSMA-targeted docetaxel nanoparticle with a differentiated pharmacological profile. Sci Transl Med. 2012 Apr 4;4(128):128ra39. doi: 10.1126/scitranslmed.3003651.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   United States
 
 
NCT01792479
BIND-014-005
Not Provided
Not Provided
Not Provided
BIND Therapeutics
BIND Therapeutics
Not Provided
Not Provided
BIND Therapeutics
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP