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 Overview
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Brief Summary
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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).

Official Title
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An Open Label, Multicenter, 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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: BIND-014


Participation Criteria
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Eligibility Criteria
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Inclusion 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 Exclusion 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: BIND-014 every 3 weeks<br> | Drug: BIND-014<br> <br> |
| Experimental: Arm B: BIND-014 weekly<br> | Drug: BIND-014<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with either a complete or partial response | To determine the efficacy of BIND-014 as measured by objective response rate (ORR) in patients with Stage III/IV Non-small cell lung cancer (NSCLC) who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease. | Patients will be followed for the duration of treatment, an expected average of 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who experience adverse events | To assess the safety and tolerability of BIND-014 | Patients will be followed for the duration of treatment, an expected average of 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, lung cancer