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

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBIND-014

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 15, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?17 U.S. locations

Locations may change over time.

Who runs it?BIND Therapeutics

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: BIND Therapeutics
Interventions being studied: Drug: BIND-014

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Chemotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Investigative Site #10Goodyear, Arizona
Investigative Site #04Los Angeles, California
Investigative Site #02Fort Meyers, Florida
Investigative Site #08Newnan, Georgia
Investigative Site #07Zion, Illinois
Investigative Site #03Columbus, Ohio
Investigative Site #09Tulsa, Oklahoma
Investigative Site #11Philadelphia, Pennsylvania
Investigative Site #05Pittsburgh, Pennsylvania
Investigative Site #01Nashville, Tennessee
Investigative Site #15Chelyabinsk
Site #17Krasnodar

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 15, 2016. Always confirm current availability with the study team.

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