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

Completed · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT01792479

Run by

BIND Therapeutics

People needed

64

Starts

2013-04-01

Expected to finish

2016-04-01

Last updated by the study team

2016-04-15

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
• 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 #10 — Goodyear, Arizona, United States
• Investigative Site #04 — Los Angeles, California, United States
• Investigative Site #02 — Fort Meyers, Florida, United States
• Investigative Site #08 — Newnan, Georgia, United States
• Investigative Site #07 — Zion, Illinois, United States
• Investigative Site #03 — Columbus, Ohio, United States
• Investigative Site #09 — Tulsa, Oklahoma, United States
• Investigative Site #11 — Philadelphia, Pennsylvania, United States
• Investigative Site #05 — Pittsburgh, Pennsylvania, United States
• Investigative Site #01 — Nashville, Tennessee, United States
• Investigative Site #15 — Chelyabinsk, Russia
• Site #17 — Krasnodar, Russia
• Investigative Site #12 — Moscow, Russia
• Site # 18 — Saint Petersburg, Russia
• Investigative Site #14 — Saint-Petersberg, Russia
• Investigative Site #13 — Saint-Petersberg, Russia
• Investigative Site #16 — Ufa, Russia

Full record on ClinicalTrials.gov

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