Clinical trial NCT02283320: A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell 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 a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: KRAS Positive Patients With Non-small Cell Lung Cancer
Squamous Cell Non-small Cell Lung Cancer
Lead sponsor: BIND Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-11-05
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.


Eligibility criteria: Inclusion Criteria:

* Males or females at least 18 years of age
* Diagnosis of NSCLC with locally advanced or metastatic disease
* Positive for KRAS mutation or Squamous cell histology
* 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: Disease control rate
timeFrame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Secondary outcomes:
measure: Progression-free survival
timeFrame: Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks.
measure: Overall survival
timeFrame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
measure: Duration of response
timeFrame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
measure: Time to response
timeFrame: change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug
measure: Disease control rate
timeFrame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
measure: Safety and tolerability, as measured by number of participants with adverse events.
timeFrame: Measured from first dose of study drug until 30 days after study discontinuation.
measure: Objective response rate
timeFrame: change in tumour size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected 12 weeks,
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Investigative Site: #51
state: Arizona
city: Goodyear
country: United States
facility: Investigative Site: #30
state: Arizona
city: Phoenix
country: United States
facility: Investigative Site: #44
state: Arizona
city: Sedona
country: United States
facility: Investigative Site: #41
state: Arizona
city: Duarte
country: United States
facility: Investigative Site: #58
state: California
city: La Jolla
country: United States
facility: Investigative Site: #47
state: California
city: Los Angeles
country: United States
facility: Investigative Site: #32
state: California
city: San Francisco
country: United States
facility: Investigative Site: #50
state: California
city: Fort Meyers
country: United States
facility: Investigative Site: #46
state: Florida
city: Newnan
country: United States
facility: Investigative Site: #53
state: Georgia
city: Savannah
country: United States
facility: Investigative Site: #56
state: Georgia
city: Zion
country: United States
facility: Investigative Site: #35
state: Illinois
city: Las Vegas
country: United States
facility: Investigative Site: #36
state: Nevada
city: Portland
country: United States
facility: Investigative Site: #60
state: Oregon
city: Pittsburgh
country: United States
facility: Investigative Site: # 59
state: Pennsylvania
city: Pittsburg
country: United States
facility: Investigative Site: #34
state: Pennsylvania
city: Amarillo
country: United States
facility: Investigative Site: #39
state: Texas
city: Dallas
country: United States
facility: Investigative Site: #42
state: Texas
city: Dallas
country: United States
facility: Investigative Site: 38
state: Texas
city: Blacksburg
country: United States
facility: Investigative Site: #40
state: Virginia
city: Vancouver
country: United States
facility: Investigative Site: #45
state: Washington
city: Yakima
country: United States
facility: Investigative Site: #37
state: Washington
city: Ufa
country: Russian Federation
facility: Investigative Site: #72
state: Bashkortastan
city: Istra settle.
country: Russian Federation
facility: Investigative Site: #75
state: Moscow Region
city: Archangelsk
country: Russian Federation
facility: Investigative Site: #74
city: Kazan
country: Russian Federation
facility: Investigative Site: #78
city: Moscow
country: Russian Federation
facility: Investigative Site: #70
city: Rostov-on-Don
country: Russian Federation
facility: Investigative Site: #79
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #76
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #71
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #73
city: Saint Petersburg
country: Russian Federation
facility: Investigative Site: #77
Study officials:
References: