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

BIND Therapeutics

Status and phase: Completed; Phase 2

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

Treatments: Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02283320

BIND-014-007

Details and patient eligibility

About

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.

Enrollment: 69 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
• 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

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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Experimental group

Treatment:

Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)