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
1 other identifier
interventional
64
2 countries
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Apr 2013
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 15, 2016
April 1, 2016
3 years
February 12, 2013
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with either a complete or partial response
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 Outcomes (1)
Number of patients who experience adverse events
Patients will be followed for the duration of treatment, an expected average of 18 weeks
Study Arms (2)
Arm A: BIND-014 every 3 weeks
EXPERIMENTALArm B: BIND-014 weekly
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Investigative Site #10
Goodyear, Arizona, 85338, United States
Investigative Site #04
Los Angeles, California, 90048, United States
Investigative Site #02
Fort Meyers, Florida, 33905, United States
Investigative Site #08
Newnan, Georgia, 30265, United States
Investigative Site #07
Zion, Illinois, 60099, United States
Investigative Site #03
Columbus, Ohio, 43221, United States
Investigative Site #09
Tulsa, Oklahoma, 74133, United States
Investigative Site #11
Philadelphia, Pennsylvania, 19124, United States
Investigative Site #05
Pittsburgh, Pennsylvania, 15232, United States
Investigative Site #01
Nashville, Tennessee, 37203, United States
Investigative Site #15
Chelyabinsk, 454087, Russia
Site #17
Krasnodar, Russia
Investigative Site #12
Moscow, 115478, Russia
Site # 18
Saint Petersburg, Russia
Investigative Site #14
Saint-Petersberg, 198255, Russia
Investigative Site #13
Saint-Petersberg, 97758, Russia
Investigative Site #16
Ufa, 450054, Russia
Related Publications (1)
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.
PMID: 22491949BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2013
First Posted
February 15, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 15, 2016
Record last verified: 2016-04