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
NCT ID: NCT01792479
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2013-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A: BIND-014 every 3 weeks
BIND-014
Arm B: BIND-014 weekly
BIND-014
Interventions
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BIND-014
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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BIND Therapeutics
INDUSTRY
Responsible Party
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Locations
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Investigative Site #10
Goodyear, Arizona, United States
Investigative Site #04
Los Angeles, California, United States
Investigative Site #02
Fort Meyers, Florida, United States
Investigative Site #08
Newnan, Georgia, United States
Investigative Site #07
Zion, Illinois, United States
Investigative Site #03
Columbus, Ohio, United States
Investigative Site #09
Tulsa, Oklahoma, United States
Investigative Site #11
Philadelphia, Pennsylvania, United States
Investigative Site #05
Pittsburgh, Pennsylvania, United States
Investigative Site #01
Nashville, Tennessee, United States
Investigative Site #15
Chelyabinsk, , Russia
Site #17
Krasnodar, , Russia
Investigative Site #12
Moscow, , Russia
Site # 18
Saint Petersburg, , Russia
Investigative Site #14
Saint-Petersberg, , Russia
Investigative Site #13
Saint-Petersberg, , Russia
Investigative Site #16
Ufa, , Russia
Countries
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References
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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.
Other Identifiers
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BIND-014-005
Identifier Type: -
Identifier Source: org_study_id
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