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

Completed · Phase 2

Conditions studied: KRAS Positive Patients With Non-small Cell Lung Cancer, Squamous Cell Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02283320

Run by

BIND Therapeutics

People needed

69

Starts

2014-09-01

Expected to finish

2016-04-01

Last updated by the study team

2016-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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