Clinical trial NCT01792479: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
lung cancer
Lead sponsor: BIND Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Number of patients with either a complete or partial response
timeFrame: Patients will be followed for the duration of treatment, an expected average of 18 weeks
Secondary outcomes:
measure: Number of patients who experience adverse events
timeFrame: Patients will be followed for the duration of treatment, an expected average of 18 weeks
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Investigative Site #10
state: Arizona
city: Los Angeles
country: United States
facility: Investigative Site #04
state: California
city: Fort Meyers
country: United States
facility: Investigative Site #02
state: Florida
city: Newnan
country: United States
facility: Investigative Site #08
state: Georgia
city: Zion
country: United States
facility: Investigative Site #07
state: Illinois
city: Columbus
country: United States
facility: Investigative Site #03
state: Ohio
city: Tulsa
country: United States
facility: Investigative Site #09
state: Oklahoma
city: Philadelphia
country: United States
facility: Investigative Site #11
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigative Site #05
state: Pennsylvania
city: Nashville
country: United States
facility: Investigative Site #01
state: Tennessee
city: Chelyabinsk
country: Russian Federation
facility: Investigative Site #15
city: Krasnodar
country: Russian Federation
facility: Site #17
city: Moscow
country: Russian Federation
facility: Investigative Site #12
city: Saint Petersburg
country: Russian Federation
facility: Site # 18
city: Saint-Petersberg
country: Russian Federation
facility: Investigative Site #14
city: Saint-Petersberg
country: Russian Federation
facility: Investigative Site #13
city: Ufa
country: Russian Federation
facility: Investigative Site #16
Study officials:
References:
citation: 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.