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

BIND Therapeutics

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: BIND-014

Study type: Interventional

Funder types: Industry

Identifiers

NCT01792479

BIND-014-005

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Arm A: BIND-014 every 3 weeks

Experimental group

Treatment:

Drug: BIND-014

Arm B: BIND-014 weekly

Experimental group

Treatment:

Drug: BIND-014