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
NCT ID: NCT02283320
Last Updated: 2016-04-18
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2014-09-30
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT01792479
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
NCT01933932
Selinexor and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Lung Cancer
NCT02536495
Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer
NCT02642042
An Open-label Study of GSK1120212 Compared With Docetaxel in Stage IV KRAS-mutant Non-small Cell Lung Cancer
NCT01362296
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Meet the organizations funding or collaborating on the study and learn about their roles.
BIND Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigative Site: #51
Chandler, Arizona, United States
Investigative Site: #30
Goodyear, Arizona, United States
Investigative Site: #44
Phoenix, Arizona, United States
Investigative Site: #41
Sedona, Arizona, United States
Investigative Site: #58
Duarte, California, United States
Investigative Site: #47
La Jolla, California, United States
Investigative Site: #32
Los Angeles, California, United States
Investigative Site: #50
San Francisco, California, United States
Investigative Site: #46
Fort Meyers, Florida, United States
Investigative Site: #53
Newnan, Georgia, United States
Investigative Site: #56
Savannah, Georgia, United States
Investigative Site: #35
Zion, Illinois, United States
Investigative Site: #36
Las Vegas, Nevada, United States
Investigative Site: #60
Portland, Oregon, United States
Investigative Site: #34
Pittsburgh, Pennsylvania, United States
Investigative Site: # 59
Pittsburgh, Pennsylvania, United States
Investigative Site: #39
Amarillo, Texas, United States
Investigative Site: #42
Dallas, Texas, United States
Investigative Site: 38
Dallas, Texas, United States
Investigative Site: #40
Blacksburg, Virginia, United States
Investigative Site: #45
Vancouver, Washington, United States
Investigative Site: #37
Yakima, Washington, United States
Investigative Site: #72
Ufa, Bashkortastan, Russia
Investigative Site: #75
Istra Settle., Moscow Oblast, Russia
Investigative Site: #74
Arkhangelsk, , Russia
Investigative Site: #78
Kazan', , Russia
Investigative Site: #70
Moscow, , Russia
Investigative Site: #79
Rostov-on-Don, , Russia
Investigative Site: #76
Saint Petersburg, , Russia
Investigative Site: #71
Saint Petersburg, , Russia
Investigative Site: #73
Saint Petersburg, , Russia
Investigative Site: #77
Saint Petersburg, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIND-014-007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.