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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Disease control rate
Time frame: 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
Progression-free survival
Time frame: 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.
Overall survival
Time frame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Duration of response
Time frame: 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
Time to response
Time frame: 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
Disease control rate
Time frame: 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
Safety and tolerability, as measured by number of participants with adverse events.
Time frame: Measured from first dose of study drug until 30 days after study discontinuation.
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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
...and 22 more locations
Objective response rate
Time frame: 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,